Updated 22 October 2026
In-vitro diagnostics distributors in India: 53 licensed establishments
The Bastion Hale Distributor Index lists 53 establishments in India whose registry records include in-vitro diagnostics: 2 with a channel role (importer, distributor, wholesaler or authorised representative), 3 registration holders without a channel role, and 48 registered as manufacturer or exporter only, out of 378 medical device establishments in India 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 | 2 | 4% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 3 | 6% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 53 | 100% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 8 | 15% | 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 India
In India the CDSCO import licence is held by an Indian authorised agent appointed by the manufacturer. The agent can be a distributor or an independent regulatory firm; the licence follows the agent.
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 | Heuer International (A division of GST Corporation Limited) NOIDA Uttar Pradesh | Channel Distributor, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 226 | 1 | 0 | 42.7 | 3/5 |
| 2 | Harsoria Healthcare Pvt. Ltd. (Unit-2) Baddi Himachal Pradesh | Channel Distributor, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +2 more | 26 | 1 | 0 | 33.5 | 3/5 |
| 3 | Harsoria Healthcare Pvt. Ltd. Gurgoon Haryana | Holder Registration holder, Manufacturer | Cardiovascular, General hospital and consumables, In-vitro diagnostics +1 more | 19 | 9 | 0 | 41.4 | 3/5 |
| 4 | Hindustan Syringes & Medical Devices Ltd. Faridabad Haryana | Holder Registration holder, Manufacturer | General hospital and consumables, In-vitro diagnostics | 14 | 8 | 0 | 39.4 | 3/5 |
| 5 | Beckman Coulter India Private Limited Bengaluru (Bangalore) Urban Karnataka, KA | Holder Registration holder, Manufacturer | In-vitro diagnostics | 4 | 3 | 0 | 30.0 | 3/5 |
| 6 | GREENS SURGICALS PRIVATE LIMITED Vadodara Gujarat | Manufacturer Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 193 | 1 | 0 | 39.6 | 3/5 |
| 7 | NARANG MEDICAL, LTD. New Delhi | Manufacturer Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 143 | 1 | 0 | 38.1 | 3/5 |
| 8 | Auxein medical Private limited Sonipat Haryana | Manufacturer Manufacturer | Anaesthesia and respiratory, General hospital and consumables, Dental +5 more | 91 | 1 | 0 | 35.8 | 3/5 |
| 9 | APOTHECARIES SUNDRIES MFG PVT LTD GURUGRAM Haryana | Manufacturer Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +8 more | 86 | 1 | 0 | 35.6 | 3/5 |
| 10 | M/S TARUN ENTERPRISES Prayagraj, Uttar Pradesh | Manufacturer Manufacturer | In-vitro diagnostics, Ophthalmic, Surgery and endoscopy | 86 | 1 | 0 | 35.6 | 3/5 |
| 11 | HOSPITAL EQUIPMENT MFG. CO. NOIDA Uttar Pradesh | Manufacturer Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 81 | 1 | 0 | 35.3 | 3/5 |
| 12 | HIMEDIA LABORATORIES PRIVATE LIMITED DOMBIVLI, THANE Maharashtra | Manufacturer Manufacturer | In-vitro diagnostics | 39 | 3 | 0 | 34.9 | 3/5 |
| 13 | MARK ENTERPRISES Nashik Maharashtra | Manufacturer Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 74 | 1 | 0 | 34.8 | 3/5 |
| 14 | ENDONEST MEDICAL SYSTEMS LLP PALGHAR Maharashtra | Manufacturer Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 72 | 1 | 0 | 34.7 | 3/5 |
| 15 | Lords Mark Industries Ltd. Daman and Diu Dadra and Nagar Haveli | Manufacturer Manufacturer | General hospital and consumables, Gastroenterology, urology and OB/GYN, In-vitro diagnostics +4 more | 71 | 1 | 0 | 34.6 | 3/5 |
| 16 | Microtrol Sterilisation Services Pvt. Ltd. Rewari Haryana | Manufacturer Manufacturer | Cardiovascular, General hospital and consumables, Dental +3 more | 40 | 2 | 0 | 33.7 | 3/5 |
| 17 | MARKEN HEALTHTECH LIMITED NASHIK Maharashtra | Manufacturer Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 52 | 1 | 0 | 33.1 | 3/5 |
| 18 | LAPAROMED PRIVATE LIMITED Mumbai Maharashtra | Manufacturer Manufacturer | General hospital and consumables, Dental, Ear, nose and throat +6 more | 51 | 1 | 0 | 33.0 | 3/5 |
| 19 | KDANS SURGICAL PRIVATE LIMITED GANDHINAGAR Gujarat | Manufacturer Manufacturer, Exporter | Dental, In-vitro diagnostics, Patient monitoring and neurology +2 more | 32 | 1 | 0 | 32.9 | 3/5 |
| 20 | UNITED POLY ENGINEERING PVT. LTD. NEW DELHI | Manufacturer Manufacturer | Anaesthesia and respiratory, General hospital and consumables, Ear, nose and throat +6 more | 42 | 1 | 0 | 32.0 | 3/5 |
Questions about in-vitro diagnostics distributors in India
How many in-vitro diagnostics distributors are there in India?
The Index counts 53 establishments in India with in-vitro diagnostics in their registry record, of which 2 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 India?
In India the CDSCO import licence is held by an Indian authorised agent appointed by the manufacturer. The agent can be a distributor or an independent regulatory firm; the licence follows the agent.
How do I find a in-vitro diagnostics distributor in India?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and India 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 India?
A company that appears in a public regulatory registry with an address in India 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 India
In-vitro diagnostics in other Asia Pacific markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 53 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 3 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.