Updated 22 October 2026
In-vitro diagnostics distributors in Hong Kong: 27 licensed establishments
The Bastion Hale Distributor Index lists 27 establishments in Hong Kong whose registry records include in-vitro diagnostics: 1 with a channel role (importer, distributor, wholesaler or authorised representative), 0 registration holders without a channel role, and 26 registered as manufacturer or exporter only, 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.
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; the Next 10 Markets report covers it for your target markets.
Top 20 in-vitro diagnostics establishments by size
Channel roles first, then registration holders, then manufacturers. Size is a 0 to 100 score; Complete is 0 to 5.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | UAN Healthcare Limited CENTRAL | Channel Distributor | General hospital and consumables, In-vitro diagnostics, Patient monitoring and neurology +2 more | 28 | 2 | 0 | 35.3 | 3/5 |
| 2 | CBR ENTERPRISE LIMITED Hong Kong | Manufacturer Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 698 | 1 | 0 | 46.1 | 3/5 |
| 3 | WORLDWIDE SUPPLIES LIMITED Hong Kong | Manufacturer Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +8 more | 262 | 1 | 0 | 41.2 | 3/5 |
| 4 | Merit Medical Asia Company Limited Tsim Sha Tsui | Manufacturer Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +6 more | 245 | 1 | 0 | 40.8 | 3/5 |
| 5 | I-MEDICAL ASIA COMPANY LIMITED Kowloon Bay | Manufacturer Exporter | General hospital and consumables, Gastroenterology, urology and OB/GYN, In-vitro diagnostics +3 more | 161 | 1 | 0 | 38.7 | 3/5 |
| 6 | HONG KONG MEDSOURCING LIMITED KOWLOON | Manufacturer Exporter | Cardiovascular, General hospital and consumables, Dental +3 more | 60 | 1 | 0 | 33.8 | 3/5 |
| 7 | Amphenol Cable and Interconnect Technologies Asia Pacific Ltd. Tsimshatsui, Kowloon | Manufacturer Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +6 more | 51 | 1 | 0 | 33.0 | 3/5 |
| 8 | Fourstar Group Kowloon | Manufacturer Exporter | Anaesthesia and respiratory, General hospital and consumables, Dental +6 more | 45 | 1 | 0 | 32.3 | 3/5 |
| 9 | Premium Plus International Limited Hong Kong | Manufacturer Manufacturer, Exporter | General hospital and consumables, Dental, In-vitro diagnostics +3 more | 28 | 1 | 0 | 32.3 | 3/5 |
| 10 | 3H APOTHEKE LIMITED Hong Kong | Manufacturer Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, In-vitro diagnostics +2 more | 20 | 1 | 0 | 30.6 | 3/5 |
| 11 | U&U MEDICAL TECHNOLOGY CO., LTD hongkong | Manufacturer Manufacturer, Exporter | General hospital and consumables, Dental, Gastroenterology, urology and OB/GYN +2 more | 14 | 1 | 0 | 28.9 | 3/5 |
| 12 | HEALTHCARE TECHNOLOGY INTERNATIONAL LTD. Shek Mun, Shatin | Manufacturer Exporter | Cardiovascular, General hospital and consumables, Gastroenterology, urology and OB/GYN +4 more | 22 | 1 | 0 | 28.8 | 3/5 |
| 13 | WARRENSLOVE(HONGKONG)LIMITED Kowloon | Manufacturer Manufacturer, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +3 more | 13 | 1 | 0 | 28.6 | 3/5 |
| 14 | HEBEI MITA TECHNOLOGY LIMITED Hong Kong | Manufacturer Manufacturer | Aesthetics, dermatology and lasers, General hospital and consumables, Dental +5 more | 20 | 1 | 0 | 28.4 | 3/5 |
| 15 | OMAN MEDICAL BEAUTY MANUFACTURE LIMITED Hong Kong | Manufacturer Manufacturer | Aesthetics, dermatology and lasers, General hospital and consumables, Dental +5 more | 20 | 1 | 0 | 28.4 | 3/5 |
| 16 | GORGEOUS BEAUTY EQUIPMENT MANUFACTURE LIMITED Hong Kong | Manufacturer Manufacturer | Aesthetics, dermatology and lasers, General hospital and consumables, Dental +4 more | 19 | 1 | 0 | 28.1 | 3/5 |
| 17 | HEBEI MITA BIOTECHNOLOGY LIMITED Hong Kong | Manufacturer Manufacturer | Aesthetics, dermatology and lasers, Dental, Gastroenterology, urology and OB/GYN +4 more | 18 | 1 | 0 | 27.9 | 3/5 |
| 18 | HIAN (HONG KONG) CO., LIMITED Hong Kong | Manufacturer Exporter | Cardiovascular, General hospital and consumables, Ear, nose and throat +1 more | 17 | 1 | 0 | 27.6 | 3/5 |
| 19 | AMSINO MEDICAL GROUP (HK) COMPANY LIMITED HONG KONG | Manufacturer Exporter | Anaesthesia and respiratory, General hospital and consumables, Gastroenterology, urology and OB/GYN +1 more | 13 | 1 | 0 | 26.3 | 3/5 |
| 20 | DELTA INTERNATIONAL TRADE ASIA PACIFIC LTD. Kowloon | Manufacturer Exporter | General hospital and consumables, Dental, In-vitro diagnostics +2 more | 10 | 1 | 0 | 25.1 | 3/5 |
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 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from US FDA (openFDA) and Health Canada and was last refreshed on 22 October 2026.
Who can hold a 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; the Next 10 Markets report covers it for your target markets.
How do I find a 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 reveal three profiles. For a ranked shortlist for your device, get the Next 10 Markets report.
What does the Distributor Index count as a 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 22 October 2026. Each establishment is counted once per country after resolving names across sources. Named individuals are never collected.
Registry data. Bastion Hale does not vouch for any establishment.