Updated 23 October 2026
In-vitro diagnostics distributors in Hong Kong: 27 licensed establishments
Hong Kong has 1 independent distributor in the Index so far.
The Bastion Hale Distributor Index lists 27 establishments in Hong Kong whose registry records include in-vitro diagnostics: 1 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 0 manufacturers' own import or sales entities, 0 regulatory representatives, and 26 manufacturers or exporters, out of 249 medical device establishments in Hong Kong overall. The records come from US FDA (openFDA) and Health Canada, last seen on 22 October 2026.
Listed
Independent distributors in the Index here, ranked by the lines each distributor carries, then registrations, then size.
- 1UAN Healthcare LimitedCENTRAL0 lines2 registrationssize 35.3
Include manufacturers, their own sales entities and regulatory representatives (26)
Manufacturers, companies that are a manufacturer's own import or sales arm, and regulatory representatives (authorised representatives, sponsors or registration holders with no import or distribution role). They are registered here but are not independent distributors.
- 1CBR ENTERPRISE LIMITEDHong Kong0 lines1 registrationsize 46.1
- 2WORLDWIDE SUPPLIES LIMITEDHong Kong0 lines1 registrationsize 41.2
- 3Merit Medical Asia Company LimitedTsim Sha Tsui0 lines1 registrationsize 40.8
- 4I-MEDICAL ASIA COMPANY LIMITEDKowloon Bay0 lines1 registrationsize 38.7
- 50 lines1 registrationsize 33.8
- 6Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.Tsimshatsui, Kowloon0 lines1 registrationsize 33.0
- 7Fourstar GroupKowloon0 lines1 registrationsize 32.3
- 8Premium Plus International LimitedHong Kong0 lines1 registrationsize 32.3
- 93H APOTHEKE LIMITEDHong Kong0 lines1 registrationsize 30.6
- 10U&U MEDICAL TECHNOLOGY CO., LTDhongkong0 lines1 registrationsize 28.9
- 11HEALTHCARE TECHNOLOGY INTERNATIONAL LTD.Shek Mun, Shatin0 lines1 registrationsize 28.8
- 12WARRENSLOVE(HONGKONG)LIMITEDKowloon0 lines1 registrationsize 28.6
- 13HEBEI MITA TECHNOLOGY LIMITEDHong Kong0 lines1 registrationsize 28.4
- 140 lines1 registrationsize 28.4
- 150 lines1 registrationsize 28.1
- 16HEBEI MITA BIOTECHNOLOGY LIMITEDHong Kong0 lines1 registrationsize 27.9
- 17HIAN (HONG KONG) CO., LIMITEDHong Kong0 lines1 registrationsize 27.6
- 180 lines1 registrationsize 26.3
- 190 lines1 registrationsize 25.1
- 20PHASE SCIENTIFIC INTERNATIONAL LIMITEDShatin NT, HONG KONG0 lines1 registrationsize 23.4
See Singapore: 439 independent distributors
Distributor in Hong Kong? Add your company, free
In-vitro diagnostics covers analysers, reagents, rapid tests and laboratory consumables across chemistry, haematology, microbiology, immunology and genetics. IVD has its own regulation in most markets, and the EU regulates it under IVDR rather than MDR. Laboratory distributors usually differ from device distributors, even inside the same company.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Distributor | 1 | 4% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Manufacturer | 12 | 44% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 20 | 74% | Registered with the US FDA as an exporter of devices made for export. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in Hong Kong
Who holds the registration varies by market and often sits with the local importer. Check the national rule before signing a distributor.
This is the general rule, not legal advice. The registration clause in the first distributor contract decides who controls the market later. The Next 10 Markets report covers who holds the registration in each of your ten markets.
Questions about in-vitro diagnostics distributors in Hong Kong
How many in-vitro diagnostics distributors are there in Hong Kong?
The Index counts 27 establishments in Hong Kong with in-vitro diagnostics in their registry record, of which 1 are independent distributors (a channel role and no manufacturing of their own). The number comes from US FDA (openFDA) and Health Canada and was last refreshed on 23 October 2026.
Who can hold an in-vitro diagnostics device registration in Hong Kong?
Who holds the registration varies by market and often sits with the local importer. Check the national rule before signing a distributor.
How do I find an in-vitro diagnostics distributor in Hong Kong?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Hong Kong to see the top three names. For a ranked shortlist for your device, see the Next 10 Markets report.
What does the Distributor Index count as an in-vitro diagnostics distributor in Hong Kong?
A company that appears in a public regulatory registry with an address in Hong Kong and whose linked device listings fall in the in-vitro diagnostics segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
Other segments in Hong Kong
In-vitro diagnostics in other Asia Pacific markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 27 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 1 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
Index build 23 October 2026. Each establishment is counted once per country after resolving names across sources. Company records only, as the registries publish them.
Registry data. Bastion Hale does not vouch for any establishment.