Updated 22 October 2026
Medical device distributors in Romania: 872 licensed establishments
The Bastion Hale Distributor Index lists 872 medical device establishments registered with an address in Romania: 702 with a channel role (importer, distributor, wholesaler or authorised representative), 0 registration holders without a channel role, and 170 registered as manufacturer or exporter only. The records come from EUDAMED and US FDA (openFDA), last seen on 22 October 2026.
By segment
| Segment | Establishments | |
|---|---|---|
| Surgery and endoscopy | 2 | Search in the Index |
| Cardiovascular | 2 | Search in the Index |
| Gastroenterology, urology and OB/GYN | 3 | Search in the Index |
| Dental | 2 | Search in the Index |
| Anaesthesia and respiratory | 2 | Search in the Index |
| Patient monitoring and neurology | 4 | Search in the Index |
| Ophthalmic | 1 | Search in the Index |
| General hospital and consumables | 4 | Search in the Index |
| No segment in the registry record | 859 |
Segments come from the device listings linked to each establishment, so one company can appear in several rows. Imaging and radiology are shown because the registries contain them; Bastion Hale's launch services do not cover them.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 673 | 77% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Authorised representative | 46 | 5% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Manufacturer | 213 | 24% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 2 | 0% | 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 Romania
In the EU and EEA the manufacturer, or its EU authorised representative for manufacturers based outside the EU, registers in EUDAMED and holds the CE marking file. Importers and distributors register separately as economic operators and never own the registration, which is why EU channel changes are easier than elsewhere.
This is the general rule, not legal advice. The registration clause in the first distributor contract decides who controls the market later; the Audit covers it per market.
Top 20 establishments by size
Channel roles (importer, distributor, wholesaler, authorised representative) are listed first, then registration holders, then manufacturers. Size is a 0 to 100 score built from products listed, registrations held, roles, sources and principals represented. Complete is 0 to 5 for website, address, segments, principals and counts.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | Hamilton Central Europe Giarmata | Channel Importer, Manufacturer | Anaesthesia and respiratory | 3 | 1 | 0 | 25.6 | 3/5 |
| 2 | S.C. Cattus S.R.L. Târgu Mureş | Channel Importer, Authorised representative, Manufacturer | No segment in record | 0 | 0 | 0 | 13.5 | 2/5 |
| 3 | QUALITECH INTERNATIONAL S.R.L. Botoşani | Channel Importer, Authorised representative, Manufacturer | No segment in record | 0 | 0 | 0 | 13.5 | 1/5 |
| 4 | Antonia Conf SRL Bucuresti | Channel Importer, Manufacturer | No segment in record | 0 | 0 | 0 | 11.9 | 2/5 |
| 5 | Avant Maris Medical CIOLPANI/ILFOV | Channel Importer, Manufacturer | No segment in record | 0 | 0 | 0 | 11.9 | 2/5 |
| 6 | AVENA MEDICA SRL CHITILA | Channel Importer, Manufacturer | No segment in record | 0 | 0 | 0 | 11.9 | 2/5 |
| 7 | Biosintex SRL Bucuresti | Channel Importer, Manufacturer | No segment in record | 0 | 0 | 0 | 11.9 | 2/5 |
| 8 | Coramed Medizinische Produkte SRL Bucuresti | Channel Importer, Manufacturer | No segment in record | 0 | 0 | 0 | 11.9 | 2/5 |
| 9 | DDS DIAGNOSTIC S.R.L. Bucuresti | Channel Importer, Manufacturer | No segment in record | 0 | 0 | 0 | 11.9 | 2/5 |
| 10 | Deluxe Medicrafts srl Bucuresti | Channel Importer, Manufacturer | No segment in record | 0 | 0 | 0 | 11.9 | 2/5 |
| 11 | DREAVIA PHARMA S.R.L. Bucharest | Channel Importer, Manufacturer | No segment in record | 0 | 0 | 0 | 11.9 | 2/5 |
| 12 | Fiterman Pharma SRL Iasi | Channel Importer, Manufacturer | No segment in record | 0 | 0 | 0 | 11.9 | 2/5 |
| 13 | FRAMED MEDICAL DEVICE SRL Bucuresti | Channel Importer, Authorised representative | No segment in record | 0 | 0 | 0 | 11.9 | 2/5 |
| 14 | Global Treat srl Galati | Channel Authorised representative, Manufacturer | No segment in record | 0 | 0 | 0 | 11.9 | 2/5 |
| 15 | HOSPITAL TECHNICAL SOLUTIONS SRL BUCURESTI | Channel Importer, Manufacturer | No segment in record | 0 | 0 | 0 | 11.9 | 2/5 |
| 16 | Inter Capital SRL Sibiu | Channel Importer, Authorised representative | No segment in record | 0 | 0 | 0 | 11.9 | 2/5 |
| 17 | Korex Medical Devices SRL Bucharest | Channel Importer, Authorised representative | No segment in record | 0 | 0 | 0 | 11.9 | 2/5 |
| 18 | LINDE GAZ ROMANIA S.R.L. Timisoara | Channel Importer, Manufacturer | No segment in record | 0 | 0 | 0 | 11.9 | 2/5 |
| 19 | MAGNUM s.r.l. Satu Mare | Channel Importer, Manufacturer | No segment in record | 0 | 0 | 0 | 11.9 | 2/5 |
| 20 | MEDICA Z 3 Constanta | Channel Importer, Authorised representative | No segment in record | 0 | 0 | 0 | 11.9 | 2/5 |
Questions about medical device distributors in Romania
How many medical device distributors are there in Romania?
The Index counts 872 medical device establishments registered in Romania, of which 702 hold a channel role as importer, distributor, wholesaler or authorised representative. The rest are registration holders or manufacturers. The number comes from EUDAMED and US FDA (openFDA) and was last refreshed on 22 October 2026.
Who can hold a medical device registration in Romania?
In the EU and EEA the manufacturer, or its EU authorised representative for manufacturers based outside the EU, registers in EUDAMED and holds the CE marking file. Importers and distributors register separately as economic operators and never own the registration, which is why EU channel changes are easier than elsewhere.
How do I find a medical device distributor in Romania?
Start with the segment table on this page, open the top establishments and check their roles, principals and registration counts. Then search the Index for your device and Romania to see the counts for your segment and reveal three profiles. For a shortlist with our read on each name, book the International Launch Audit.
What does the Distributor Index count as a distributor in Romania?
An establishment is a company that appears in a public regulatory registry with an address in Romania, in any of the roles importer, distributor, wholesaler, authorised representative, sponsor, registration holder, manufacturer or exporter. Each company is counted once per country even if it holds several licences or appears in several registries. No contacts or named individuals are collected.
Related markets in EU and EEA
Sources
- EUDAMED economic operator registration, European Commission public API: 860 establishments, last seen 22 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 13 establishments, last seen 22 October 2026. US government work, public domain.
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.