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Register of Exemptions

The Register of Exemptions contains details of the exemptions granted, revoked, varied or suspended.

  Name (and other identifiers) of exempted regulated product Exemption no. (HK-RPEx No.) Name of importer, local distributor and/or seller Name and country of manufacturer

Validity of exemption
(Both dates inclusive)

Extent of exemption granted under the Human Organ Transplant Ordinance (Cap. 465) (“the Ordinance”) Remarks
From
To
1 DBX® Demineralized Bone Matrix Putty:   Johnson & Johnson (Hong Kong) Ltd. MTF Musculoskeletal Transplant Foundation, USA 31/10/2011 30/10/2021 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
  1. Effective from 16 August 2012, the regulated product is exempted from the application of section 6, in addition to sections 4, 5 to 5E and 7 of the Ordinance.
  2. Effective from 30 December 2013, the importer, local distributor and/or seller of the regulated product is changed from Synthes (Hong Kong) Ltd. to Johnson & Johnson (Hong Kong) Ltd.
038005 DBX, Putty, 0.5cc 2011A-0001-1
038010 DBX, Putty, 1cc 2011A-0001-2
038025 DBX, Putty, 2.5cc 2011A-0001-3
038050 DBX, Putty, 5cc 2011A-0001-4
038100 DBX, Putty, 10cc 2011A-0001-5
2 GRAFTON® DBM Gel:   Medtronic Hong Kong Medical Limited Medtronic Sofamor Danek USA, Inc., USA 13/06/2012 12/06/2022 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
  1. Effective from 16 August 2012, the regulated product is exempted from the application of section 6, in addition to sections 4, 5 to 5E and 7 of the Ordinance.
  2. Effective from 11 March 2013, the name of manufacturer is changed from Osteotech, Inc. to Medtronic Sofamor Danek USA, Inc.; and a “T” prefix and an “INT” suffix is added to the product code.
  3. Effective from 1 September 2014, the address of one of the manufacturing sites and the package insert of the regulated product has been changed.
  4. Effective from 26 November 2016, the importer, local distributor and/or seller of the regulated product is changed from Medtronic International Ltd. to Medtronic Hong Kong Medical Limited.
T41110INT GRAFTON® DBM Gel, 0.5cc 2012B-0001-1
T41120INT GRAFTON® DBM Gel, 1cc 2012B-0001-2
T41130INT GRAFTON® DBM Gel, 5cc 2012B-0001-3
T41150INT GRAFTON® DBM Gel, 10cc 2012B-0001-4
41170 GRAFTON® DBM Gel, 25cc(Exemption revoked) 2012B-0001-5 Medtronic International Ltd. Osteotech, Inc. (a wholly owned subsidiary of Medtronic Sofamor Danek USA, Inc.), USA 13/06/2012 10/03/2013 NA Exemption revoked with effect from 11 March 2013 as the product has become obsolete.
3 GRAFTON® DBM Flex:   Medtronic Hong Kong Medical Limited Medtronic Sofamor Danek USA, Inc., USA 13/06/2012 12/06/2022 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
  1. Effective from 16 August 2012, the regulated product is exempted from the application of section 6, in addition to sections 4, 5 to 5E and 7 of the Ordinance.
  2. Effective from 11 March 2013, the name of manufacturer is changed from Osteotech, Inc. to Medtronic Sofamor Danek USA, Inc.; and a “T” prefix and an “INT” suffix is added to the product code.
  3. Effective from 1 September 2014, the address of one of the manufacturing sites and the package insert of the regulated product has been changed.
  4. Effective from 26 November 2016, the importer, local distributor and/or seller of the regulated product is changed from Medtronic International Ltd. to Medtronic Hong Kong Medical Limited.
T42090INT GRAFTON® DBM Flex, 1.5cm x 1.5cm 2012B-0002-1
T42100INT GRAFTON® DBM Flex, 2.5cm x 10cm 2012B-0002-2
T42110INT GRAFTON® DBM Flex, 2.5cm x 5cm 2012B-0002-3
T42150INT GRAFTON® DBM Flex, 5cm x 5cm 2012B-0002-4
4 GRAFTON® DBM A-FlexTM:   Medtronic Hong Kong Medical Limited Medtronic Sofamor Danek USA, Inc., USA 13/06/2012 12/06/2017 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
  1. Effective from 16 August 2012, the regulated product is exempted from the application of section 6, in addition to sections 4, 5 to 5E and 7 of the Ordinance.
  2. Effective from 11 March 2013, the name of manufacturer is changed from Osteotech, Inc. to Medtronic Sofamor Danek USA, Inc.; and a “T” prefix and an “INT” suffix is added to the product code.
  3. Effective from 1 September 2014, the address of one of the manufacturing sites and the package insert of the regulated product has been changed.
  4. Effective from 26 November 2016, the importer, local distributor and/or seller of the regulated product is changed from Medtronic International Ltd. to Medtronic Hong Kong Medical Limited.
T42160INT GRAFTON® DBM A-FlexTM, 60 mm dia 2012B-0003-1
5 GRAFTON® DBM Putty:   Medtronic Hong Kong Medical Limited Medtronic Sofamor Danek USA, Inc., USA 13/06/2012 12/06/2022 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
  1. Effective from 16 August 2012, the regulated product is exempted from the application of section 6, in addition to sections 4, 5 to 5E and 7 of the Ordinance.
  2. Effective from 11 March 2013, the name of manufacturer is changed from Osteotech, Inc. to Medtronic Sofamor Danek USA, Inc.; and a “T” prefix and an “INT” suffix is added to the product code.
  3. Effective from 1 September 2014, the address of one of the manufacturing sites and the package insert of the regulated product has been changed.
  4. Effective from 26 November 2016, the importer, local distributor and/or seller of the regulated product is changed from Medtronic International Ltd. to Medtronic Hong Kong Medical Limited.
T43204INT GRAFTON® DBM Putty, 0.25cc syringe 2012B-0004-1
T43205INT GRAFTON® DBM Putty, 0.5cc syringe 2012B-0004-2
T43101INT GRAFTON® DBM Putty, 0.5 cc jar 2012B-0004-3
T43102INT GRAFTON® DBM Putty, 1cc jar 2012B-0004-4
T43103INT GRAFTON® DBM Putty, 2.5cc jar 2012B-0004-5
T43105INT GRAFTON® DBM Putty, 5cc jar 2012B-0004-6
T43110INT GRAFTON® DBM Putty, 10cc jar 2012B-0004-7
6 GRAFTON® DBM Matrix/ Matrix Strips:   Medtronic Hong Kong Medical Limited Medtronic Sofamor Danek USA, Inc., USA 13/06/2012 12/06/2022 Section 4;
Section 5 to 5E;
Section 6; and
Section 7

 

  1. Effective from 16 August 2012, the regulated product is exempted from the application of section 6, in addition to sections 4, 5 to 5E and 7 of the Ordinance.
  2. Effective from 11 March 2013, the name of manufacturer is changed from Osteotech, Inc. to Medtronic Sofamor Danek USA, Inc.; and a “T” prefix and an “INT” suffix is added to the product code.
  3. Effective from 1 September 2014, the address of one of the manufacturing sites and the package insert of the regulated product has been changed.
  4. Effective from 26 November 2016, the importer, local distributor and/or seller of the regulated product is changed from Medtronic International Ltd. to Medtronic Hong Kong Medical Limited.
T42210INT GRAFTON® DBM Matrix, 2.5cm x 5cm (2 each) 2012B-0005-1
T42200INT GRAFTON® DBM Matrix, 2.5cm x 10cm (2 each) 2012B-0005-2
T42275INT GRAFTON® DBM Matrix Strips, 8mm x 1cm x 10cm (2 each) 2012B-0005-3
T42280INT GRAFTON® DBM Matrix Strips, 8mm x 1cm x 20cm (2 each) 2012B-0005-4
7 GRAFTON® DBM Matrix Plugs:   Medtronic Hong Kong Medical Limited Medtronic Sofamor Danek USA, Inc., USA 13/06/2012 12/06/2022 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
  1. Effective from 16 August 2012, the regulated product is exempted from the application of section 6, in addition to sections 4, 5 to 5E and 7 of the Ordinance.
  2. Effective from 11 March 2013, the name of manufacturer is changed from Osteotech, Inc. to Medtronic Sofamor Danek USA, Inc.; and a “T” prefix and an “INT” suffix is added to the product code.
  3. Effective from 1 September 2014, the address of one of the manufacturing sites and the package insert of the regulated product has been changed.
  4. Effective from 26 November 2016, the importer, local distributor and/or seller of the regulated product is changed from Medtronic International Ltd. to Medtronic Hong Kong Medical Limited.
T42308INT GRAFTON® DBM Matrix Plugs, 8mm x 10mm 2012B-0006-1
42310 GRAFTON® DBM Matrix Plugs, 10mm x 10mm (2 each) (Exemption revoked) 2012B-0006-2 Medtronic International Ltd. Osteotech, Inc. (a wholly owned subsidiary of Medtronic Sofamor Danek USA, Inc.), USA 13/06/2012 10/03/2013 NA Exemption revoked with effect from 11 March 2013 as the product has become obsolete.
42312 GRAFTON® DBM Matrix Plugs, 12mm x 10mm (2 each) (Exemption revoked) 2012B-0006-3
42314 GRAFTON® DBM Matrix Plugs, 14mm x 10mm (2 each) (Exemption revoked) 2012B-0006-4
42316 GRAFTON® DBM Matrix Plugs, 16mm x 10mm (2 each) (Exemption revoked) 2012B-0006-5
42318 GRAFTON® DBM Matrix Plugs, 18mm x 10mm (2 each) (Exemption revoked) 2012B-0006-6
8 GRAFTON® DBM Crunch:   Medtronic Hong Kong Medical Limited Medtronic Sofamor Danek USA, Inc., USA 13/06/2012 12/06/2022 Section 4;
Section 5 to 5E;
Section 6; and
Section 7

 

  1. Effective from 16 August 2012, the regulated product is exempted from the application of section 6, in addition to sections 4, 5 to 5E and 7 of the Ordinance.
  2. Effective from 11 March 2013, the name of manufacturer is changed from Osteotech, Inc. to Medtronic Sofamor Danek USA, Inc.; and a “T” prefix and an “INT” suffix is added to the product code.
  3. Effective from 1 September 2014, the address of one of the manufacturing sites and the package insert of the regulated product has been changed.
  4. Effective from 26 November 2016, the importer, local distributor and/or seller of the regulated product is changed from Medtronic International Ltd. to Medtronic Hong Kong Medical Limited.
T44105INT GRAFTON® DBM Crunch, 5cc 2012B-0007-1
T44115INT GRAFTON® DBM Crunch, 15cc 2012B-0007-2
9 GRAFTON® DBM Orthoblend:   Medtronic Hong Kong Medical Limited Medtronic Sofamor Danek USA, Inc., USA 13/06/2012 12/06/2022 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
  1. Effective from 16 August 2012, the regulated product is exempted from the application of section 6, in addition to sections 4, 5 to 5E and 7 of the Ordinance.
  2. Effective from 11 March 2013, the name of manufacturer is changed from Osteotech, Inc. to Medtronic Sofamor Danek USA, Inc.; and a “T” prefix and an “INT” suffix is added to the product code.
  3. Effective from 1 September 2014, the address of one of the manufacturing sites and the package insert of the regulated product has been changed.
  4. Effective from 26 November 2016, the importer, local distributor and/or seller of the regulated product is changed from Medtronic International Ltd. to Medtronic Hong Kong Medical Limited.
T44125INT GRAFTON® DBM Orthoblend, 5cc-Large defect 2012B-0008-1
T44135INT GRAFTON® DBM Orthoblend, 15cc-Large defect 2012B-0008-2
T44145INT GRAFTON® DBM Orthoblend, 5cc –Small defect 2012B-0008-3
T44150INT GRAFTON® DBM Orthoblend, 10cc –Small defect 2012B-0008-4
10 GRAFTON PLUS® DBM Paste:   Medtronic Hong Kong Medical Limited Medtronic Sofamor Danek USA, Inc., USA 13/06/2012 12/06/2022 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
  1. Effective from 16 August 2012, the regulated product is exempted from the application of section 6, in addition to sections 4, 5 to 5E and 7 of the Ordinance.
  2. Effective from 11 March 2013, the name of manufacturer is changed from Osteotech, Inc. to Medtronic Sofamor Danek USA, Inc.; and a “T” prefix and an “INT” suffix is added to the product code.
  3. Effective from 1 September 2014, the address of one of the manufacturing sites and the package insert of the regulated product has been changed.
  4. Effective from 26 November 2016, the importer, local distributor and/or seller of the regulated product is changed from Medtronic International Ltd. to Medtronic Hong Kong Medical Limited.
T45001INT GRAFTON PLUS® DBM Paste, 1cc 2012B-0009-1
T45005INT GRAFTON PLUS® DBM Paste, 5cc 2012B-0009-2
T45010INT GRAFTON PLUS® DBM Paste, 10cc 2012B-0009-3
11 SureOssTM-FDBA Powder:   Osstem Hong Kong Limited HansBiomed Corp., Republic of Korea 09/10/2012 08/10/2022 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
  1. Effective from 7 December 2016, the intended uses/ indications and the package insert of the regulated product has been changed.
  2. Effective from 6 June 2017, the address of the manufacturer has been changed.
SOP025 SureOssTM-FDBA Powder, 0.25cc 2012E-0010-1
SOP050 SureOssTM-FDBA Powder, 0.5cc 2012E-0010-2
SOP100 SureOssTM-FDBA Powder, 1cc 2012E-0010-3
12 SureOssTM-FDBA Chip:   Osstem Hong Kong Limited HansBiomed Corp., Republic of Korea 09/10/2012 08/10/2022 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
  1. Effective from 7 December 2016, the intended uses/ indications and the package insert of the regulated product has been changed.
  2. Effective from 6 June 2017, the address of the manufacturer has been changed.
SOC025 SureOssTM-FDBA Chip, 0.25cc 2012E-0011-1
SOC050 SureOssTM-FDBA Chip, 0.5cc 2012E-0011-2
SOC100 SureOssTM-FDBA Chip, 1cc 2012E-0011-3
13 SureOssTM-DFDBA Powder:   Osstem Hong Kong Limited HansBiomed Corp., Republic of Korea 09/10/2012 05/06/2017 NA Exemption revoked with effect from 6 June 2017 as Osstem Hong Kong Limited no longer imports the regulated product for sale in HK.
DSOP025 SureOssTM-DFDBA Powder, 0.25cc 2012E-0012-1
DSOP050 SureOssTM-DFDBA Powder, 0.5cc 2012E-0012-2
DSOP100 SureOssTM-DFDBA Powder, 1cc 2012E-0012-3
14 SureOssTM-DFDBA Chip:   Osstem Hong Kong Limited HansBiomed Corp., Republic of Korea 09/10/2012 05/06/2017 NA Exemption revoked with effect from 6 June 2017 as Osstem Hong Kong Limited no longer imports the regulated product for sale in HK.
DSOC025 SureOssTM-DFDBA Chip, 0.25cc 2012E-0013-1
DSOC050 SureOssTM-DFDBA Chip, 0.5cc 2012E-0013-2
DSOC100 SureOssTM-DFDBA Chip, 1cc 2012E-0013-3
15 OraGRAFT® Cancellous Bone Particulate:   Forever Green Dental Products Limited LifeNet Health, United States of America 09/10/2012 08/10/2022 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
Effective from 7 November 2014, the organisations responsible for procuring/ supplying human bone for producing the regulated product has been changed.
OCAN-0.5A OraGRAFT® Cancellous Bone Particulate, 0.5cc (250-1000 micron) 2012F-0014-1
OCAN-1.0A OraGRAFT® Cancellous Bone Particulate, 1cc (250-1000 micron) 2012F-0014-2
OCAN-2.0A OraGRAFT® Cancellous Bone Particulate, 2cc (250-1000 micron) 2012F-0014-3
OCAN-0.5B OraGRAFT® Cancellous Bone Particulate, 0.5cc (1-2 mm) 2012F-0014-4
OCAN-1.0B OraGRAFT® Cancellous Bone Particulate, 1cc (1-2 mm) 2012F-0014-5
OCAN-2.0B OraGRAFT® Cancellous Bone Particulate, 2cc (1-2 mm) 2012F-0014-6
16 OraGRAFT® Cancellous Bone Cubes:   Forever Green Dental Products Limited LifeNet Health, United States of America 09/10/2012 08/10/2022 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
Effective from 7 November 2014, the organisations responsible for procuring/ supplying human bone for producing the regulated product has been changed.
CANCUBE1 OraGRAFT® Cancellous Bone Cubes, 10x10x10mm 2012F-0015-1
CCUBE-01 OraGRAFT® Cancellous Bone Cubes, 15x15x15mm 2012F-0015-2
CCUBE-02 OraGRAFT® Cancellous Bone Cubes, 15x15x8mm 2012F-0015-3
CCUBE-03 OraGRAFT® Cancellous Bone Cubes, 15x30x8mm 2012F-0015-4
17 OraGRAFT® Demineralized Ground Cortical Bone:   Forever Green Dental Products Limited LifeNet Health, United States of America 09/10/2012 08/10/2022 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
Effective from 7 November 2014, the organisations responsible for procuring/ supplying human bone for producing the regulated product has been changed.
DGC 1/20 OraGRAFT® Demineralized Ground Cortical Bone, 0.25cc (250-1000 micron) 2012F-0016-1
DGC 1/10 OraGRAFT® Demineralized Ground Cortical Bone, 0.5cc (250-1000 micron) 2012F-0016-2
DGC 1/8 OraGRAFT® Demineralized Ground Cortical Bone, 0.7cc (250-1000 micron) 2012F-0016-3
DGC 1/4 OraGRAFT® Demineralized Ground Cortical Bone, 1.2cc (250-1000 micron) 2012F-0016-4
DGC OraGRAFT® Demineralized Ground Cortical Bone, 2.5cc (250-1000 micron) 2012F-0016-5
DGC 5 OraGRAFT® Demineralized Ground Cortical Bone, 5.0cc (1-4mm) 2012F-0016-6
18 OraGRAFT® Mineralized Ground Cortical Bone:   Forever Green Dental Products Limited LifeNet Health, United States of America 09/10/2012 08/10/2022 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
Effective from 7 November 2014, the organisations responsible for procuring/ supplying human bone for producing the regulated product has been changed.
GC 1/20 OraGRAFT® Mineralized Ground Cortical Bone, 0.25cc (250-1000 micron) 2012F-0017-1
GC 1/10 OraGRAFT® Mineralized Ground Cortical Bone, 0.5cc (250-1000 micron) 2012F-0017-2
GC 1/8 OraGRAFT® Mineralized Ground Cortical Bone, 0.7cc (250-1000 micron) 2012F-0017-3
GC 1/4 OraGRAFT® Mineralized Ground Cortical Bone, 1.2cc (250-1000 micron) 2012F-0017-4
GC OraGRAFT® Mineralized Ground Cortical Bone, 2.5cc (250-1000 micron) 2012F-0017-5
19 PROGENIXTM DBM Putty   Medtronic International Ltd. Medtronic Sofamor Danek USA, Inc, USA 24/01/2013 23/05/2016 NA Exemption revoked with effect from 28 June 2016 as the product is no longer marketed in HK.
000505INT PROGENIXTM DBM Putty, 0.5cc (Exemption revoked) 2013B-0001-1
005001INT PROGENIXTM DBM Putty, 1cc (Exemption revoked) 2013B-0001-2
005005INT PROGENIXTM DBM Putty, 5cc (Exemption revoked) 2013B-0001-3
005110INT PROGENIXTM DBM Putty, 10cc (Exemption revoked) 2013B-0001-4
20 Allomatrix® Injectable Putty:   Hong Kin Medical Instrument Ltd. Wright Medical Technology, Inc., USA 12/3/2013 11/3/2018 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
Effective from 8 October 2015, the addresses of the manufacturer and one of the manufacturing sites have been changed.
8600-0050 Allomatrix® Injectable Putty, 0.5cc 2013D-0002-1
8600-0100 Allomatrix® Injectable Putty, 1cc 2013D-0002-2
8600-0500 Allomatrix® Injectable Putty, 5cc 2013D-0002-3
8600-1000 Allomatrix® Injectable Putty, 10cc 2013D-0002-4
8600-2000 Allomatrix® Injectable Putty, 20cc 2013D-0002-5
21 INGROSSTM Powder:   Asia Implant Support and Services HansBiomed Corp., Republic of Korea 15/04/2014 14/04/2019 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
  1. Effective from 4 July 2017, the address of the manufacturer has been changed.
  2. Effective from 9 August 2017, the address of the importer, local distributor and/or seller has been changed.
CDP025 INGROSSTM Powder, 0.25cc 2014J-0001-1
CDP050 INGROSSTM Powder, 0.5cc 2014J-0001-2
CDP100 INGROSSTM Powder, 1cc 2014J-0001-3
22 INGROSSTM Chip:   Asia Implant Support and Services HansBiomed Corp., Republic of Korea 15/04/2014 14/04/2019 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
  1. Effective from 4 July 2017, the address of the manufacturer has been changed.
  2. Effective from 9 August 2017, the address of the importer, local distributor and/or seller has been changed.
CDC025 INGROSSTM Chip, 0.25cc 2014J-0002-1
CDC050 INGROSSTM Chip, 0.5cc 2014J-0002-2
CDC100 INGROSSTM Chip, 1cc 2014J-0002-3
23 OsteOssTM Powder:   Asia Implant Support and Services HansBiomed Corp., Republic of Korea 15/04/2014 14/04/2019 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
  1. Effective from 4 July 2017, the address of the manufacturer has been changed.
  2. Effective from 9 August 2017, the address of the importer, local distributor and/or seller has been changed.
CCP025 OsteOssTM Powder, 0.25cc 2014J-0003-1
CCP050 OsteOssTM Powder, 0.5cc 2014J-0003-2
CCP100 OsteOssTM Powder, 1cc 2014J-0003-3
24 OsteOssTM Chip:   Asia Implant Support and Services HansBiomed Corp., Republic of Korea 15/04/2014 14/04/2019 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
  1. Effective from 4 July 2017, the address of the manufacturer has been changed.
  2. Effective from 9 August 2017, the address of the importer, local distributor and/or seller has been changed.
CCC025 OsteOssTM Chip, 0.25cc 2014J-0004-1
CCC050 OsteOssTM Chip, 0.5cc 2014J-0004-2
CCC100 OsteOssTM Chip, 1cc 2014J-0004-3
25 CANOSSTM Powder:   Asia Implant Support and Services HansBiomed Corp., Republic of Korea 15/04/2014 14/04/2019 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
  1. Effective from 4 July 2017, the address of the manufacturer has been changed.
  2. Effective from 9 August 2017, the address of the importer, local distributor and/or seller has been changed.
CAP025 CANOSSTM Powder, 0.25cc 2014J-0005-1
CAP050 CANOSSTM Powder, 0.5cc 2014J-0005-2
CAP100 CANOSSTM Powder, 1cc 2014J-0005-3
26 CANOSSTM Chip:   Asia Implant Support and Services HansBiomed Corp., Republic of Korea 15/04/2014 14/04/2019 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
  1. Effective from 4 July 2017, the address of the manufacturer has been changed.
  2. Effective from 9 August 2017, the address of the importer, local distributor and/or seller has been changed.
CAC025 CANOSSTM Chip, 0.25cc 2014J-0006-1
CAC050 CANOSSTM Chip, 0.5cc 2014J-0006-2
CAC100 CANOSSTM Chip, 1cc 2014J-0006-3
27 GenesisTM Cancellous Block:   Asia Implant Support and Services HansBiomed Corp., Republic of Korea 15/04/2014 14/04/2019 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
  1. Effective from 4 July 2017, the address of the manufacturer has been changed.
  2. Effective from 9 August 2017, the address of the importer, local distributor and/or seller has been changed.
CAB05 GenesisTM Cancellous Block, 10X10X5mm 2014J-0007-1
CAB10 GenesisTM Cancellous Block, 10X10X10mm 2014J-0007-2
CAB20 GenesisTM Cancellous Block, 10X10X20mm 2014J-0007-3
28 GenesisTM CorticoCancellous Block:   Asia Implant Support and Services HansBiomed Corp., Republic of Korea 15/04/2014 14/04/2019 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
  1. Effective from 4 July 2017, the address of the manufacturer has been changed.
  2. Effective from 9 August 2017, the address of the importer, local distributor and/or seller has been changed.
CCB06 GenesisTM CorticoCancellous Block, 6X6X10mm 2014J-0008-1
CCB12 GenesisTM CorticoCancellous Block, 6X12X12mm 2014J-0008-2
CCB20 GenesisTM CorticoCancellous Block, 6X12X20mm 2014J-0008-3
CCB17 GenesisTM CorticoCancellous Block, 7X7X10mm Wedge 2014J-0008-4
29 SureOssTM-FDBA Powder:   Asia Implant Support and Services HansBiomed Corp., Republic of Korea 15/04/2014 14/04/2019 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
  1. Effective from 4 July 2017, the address of the manufacturer has been changed.
  2. Effective from 9 August 2017, the address of the importer, local distributor and/or seller has been changed.
SOP025 SureOssTM-FDBA Powder, 0.25cc 2014J-0009-1
SOP050 SureOssTM-FDBA Powder, 0.5cc 2014J-0009-2
SOP100 SureOssTM-FDBA Powder, 1cc 2014J-0009-3
30 SureOssTM-FDBA Chip:   Asia Implant Support and Services HansBiomed Corp., Republic of Korea 15/04/2014 14/04/2019 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
  1. Effective from 4 July 2017, the address of the manufacturer has been changed.
  2. Effective from 9 August 2017, the address of the importer, local distributor and/or seller has been changed.
SOC025 SureOssTM-FDBA Chip, 0.25cc 2014J-0010-1
SOC050 SureOssTM-FDBA Chip, 0.5cc 2014J-0010-2
SOC100 SureOssTM-FDBA Chip, 1cc 2014J-0010-3
31 SureOssTM-DFDBA Powder:   Asia Implant Support and Services HansBiomed Corp., Republic of Korea 15/04/2014 14/04/2019 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
  1. Effective from 4 July 2017, the address of the manufacturer has been changed.
  2. Effective from 9 August 2017, the address of the importer, local distributor and/or seller has been changed.
DSOP025 SureOssTM-DFDBA Powder, 0.25cc 2014J-0011-1
DSOP050 SureOssTM-DFDBA Powder, 0.5cc 2014J-0011-2
DSOP100 SureOssTM-DFDBA Powder, 1cc 2014J-0011-3
32 SureOssTM-DFDBA Chip:   Asia Implant Support and Services HansBiomed Corp., Republic of Korea 15/04/2014 14/04/2019 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
  1. Effective from 4 July 2017, the address of the manufacturer has been changed.
  2. Effective from 9 August 2017, the address of the importer, local distributor and/or seller has been changed.
DSOC025 SureOssTM-DFDBA Chip, 0.25cc 2014J-0012-1
DSOC050 SureOssTM-DFDBA Chip, 0.5cc 2014J-0012-2
DSOC100 SureOssTM-DFDBA Chip, 1cc 2014J-0012-3
33 OraGRAFT® Cortical/Cancellous Mix   Forever Green Dental Products Limited LifeNet Health, United States of America 7/11/2014 8/10/2022 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
 
C/CMix-0.5 OraGRAFT® Cortical/Cancellous Mix, 0.5 cc 2014F-0013-1
C/CMix-1.0 OraGRAFT® Cortical/Cancellous Mix, 1 cc 2014F-0013-2
C/CMix-2.0 OraGRAFT® Cortical/Cancellous Mix, 2 cc 2014F-0013-3
34 MinerOss® Cortical & Cancellous Chips   Henry Schein Hong Kong Limited Medtronic Sofamor Danek USA, Inc. 7/11/2016 6/11/2021 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
 
T00961INT MinerOss® Cortical & Cancellous Chips, 0.5 cc 2016C-0001-1
T00962INT MinerOss® Cortical & Cancellous Chips, 1.0 cc 2016C-0001-2
T00963INT MinerOss® Cortical & Cancellous Chips, 2.5 cc 2016C-0001-3
35 Magnifuse® Bone Graft   Medtronic Hong Kong Medical Limited Medtronic Sofamor Danek USA, Inc. 6/12/2016 5/12/2021 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
 
7509007INT Magnifuse® Small 7.5mm x 25mm 2016B-0002-1
7509010INT Magnifuse® Medium 10mm x 25mm 2016B-0002-2
7509014INT Magnifuse® Large 14mm x 25mm 2016B-0002-3
7509141INT Magnifuse® 1.75cm x 10cm 2016B-0002-4
7509145INT Magnifuse® 1.75cm x 5cm 2016B-0002-5
7509211INT Magnifuse® 1cm x 10cm 2016B-0002-6
7509212INT Magnifuse® 1cm x 20cm 2016B-0002-7
7509215INT Magnifuse® 1cm x 5cm 2016B-0002-8
7509221INT Magnifuse® 2.5cm x 10cm 2016B-0002-9
7509225INT Magnifuse® 2.5cm x 5cm 2016B-0002-10
36 SureFuse Gel   Transmedic China Limited Hans Biomed Corp., Republic of Korea 30/3/2017 29/3/2022 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
Effective from 26 April 2017, the address of the manufacturer has been changed.
SG1S SureFuse Gel, 1 cc 2017P-0001-1
SG3G SureFuse Gel, 3 cc 2017P-0001-2
SG5G SureFuse Gel, 5 cc 2017P-0001-3
SG10G SureFuse Gel, 10 cc 2017P-0001-4
37 SureFuse Putty   Transmedic China Limited Hans Biomed Corp., Republic of Korea 30/3/2017 29/3/2022 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
Effective from 26 April 2017, the address of the manufacturer has been changed.
SP1S SureFuse Putty, 1 cc 2017P-0002-1
SP3L SureFuse Putty, 3 cc 2017P-0002-2
SP5L SureFuse Putty, 5 cc 2017P-0002-3
SP10L SureFuse Putty, 10 cc 2017P-0002-4
38 ExFuse Gel   Transmedic China Limited Hans Biomed Corp., Republic of Korea 30/3/2017 29/3/2022 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
Effective from 26 April 2017, the address of the manufacturer has been changed.
EG1S ExFuse Gel, 1 cc 2017P-0003-1
EG3G ExFuse Gel, 3 cc 2017P-0003-2
EG5G ExFuse Gel, 5 cc 2017P-0003-3
EG10G ExFuse Gel, 10 cc 2017P-0003-4
39 ExFuse Putty   Transmedic China Limited Hans Biomed Corp., Republic of Korea 30/3/2017 29/3/2022 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
Effective from 26 April 2017, the address of the manufacturer has been changed.
EP1S ExFuse Putty, 1 cc 2017P-0004-1
EP3L ExFuse Putty, 3 cc 2017P-0004-2
EP5L ExFuse Putty, 5 cc 2017P-0004-3
EP10L ExFuse Putty, 10 cc 2017P-0004-4
40 Puros® Cancellous Particulate Allograft   Healthcare Dental Limited RTI Biologics, Inc., USA 15/9/2017 14/9/2022 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
 
68210 Puros® Cancellous Particulate Allograft, 250-1000 microns, 0.5 cc 2017H-0005-1
68211 Puros® Cancellous Particulate Allograft, 250-1000 microns, 1 cc 2017H-0005-2
68209 Puros® Cancellous Particulate Allograft, 250-1000 microns, 2 cc 2017H-0005-3
68212 Puros® Cancellous Particulate Allograft, 1000-2000 microns, 0.5 cc 2017H-0005-4
68213 Puros® Cancellous Particulate Allograft, 1000-2000 microns, 1 cc 2017H-0005-5
68214 Puros® Cancellous Particulate Allograft, 1000-2000 microns, 2 cc 2017H-0005-6
41 Puros® Cortico-Cancellous Particulate Allograft   Healthcare Dental Limited RTI Biologics, Inc., USA 15/9/2017 14/9/2022 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
68800 Puros® Cortico-Cancellous Particulate Allograft, 250-1000 microns, 0.5 cc 2017H-0006-1
68801 Puros® Cortico-Cancellous Particulate Allograft, 250-1000 microns, 1 cc 2017H-0006-2
68802 Puros® Cortico-Cancellous Particulate Allograft, 250-1000 microns, 2 cc 2017H-0006-3
68803 Puros® Cortico-Cancellous Particulate Allograft, 1000-2000 microns, 0.5 cc 2017H-0006-4
68804 Puros® Cortico-Cancellous Particulate Allograft, 1000-2000 microns, 1 cc 2017H-0006-5
68805 Puros® Cortico-Cancellous Particulate Allograft, 1000-2000 microns, 2 cc 2017H-0006-6
42 Puros® Cortical Particulate Allograft   Healthcare Dental Limited RTI Biologics, Inc., USA 15/9/2017 14/9/2022 Section 4;
Section 5 to 5E;
Section 6; and
Section 7
68271 Puros® Cortical Particulate Allograft, 250-1000 microns, 0.5 cc 2017H-0007-1
68272 Puros® Cortical Particulate Allograft, 250-1000 microns, 1 cc 2017H-0007-2
68273 Puros® Cortical Particulate Allograft, 250-1000 microns, 2 cc 2017H-0007-3
68274 Puros® Cortical Particulate Allograft, 1000-2000 microns, 0.5 cc 2017H-0007-4
68275 Puros® Cortical Particulate Allograft, 1000-2000 microns, 1 cc 2017H-0007-5
68276 Puros® Cortical Particulate Allograft, 1000-2000 microns, 2 cc 2017H-0007-6

The Register of Exemptions is also available for inspection, free of charge, during office hours at the following office of the Department of Health.

Address: Special Health Services
Department of Health
21/F, Wu Chung House
213 Queen's Road East, Wanchai, Hong Kong
Office hours-
Mondays to Fridays
(except public holidays):
9:00 a.m. to 1:00 p.m.; and 2:00 p.m. to 5:30 p.m.
Tel: (852) 2961 8645
Fax: (852) 2127 7329
Email: hot_rpe@dh.gov.hk

 

  Last Revision Date : 3 Oct 2017