Updated 23 October 2026
Medical device distributors in Bulgaria: 207 licensed establishments
The Bastion Hale Distributor Index lists 207 medical device establishments registered with an address in Bulgaria: 100 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 47 manufacturers' own import or sales entities, 3 regulatory representatives (authorised representatives or registration holders with no import or distribution role), and 57 manufacturers or exporters. The records come from EUDAMED, US FDA (openFDA) and MHRA UK, last seen on 23 October 2026.
Top 20 independent distributors
Independent distributors only, ranked by the lines each distributor carries for other manufacturers, then registrations held, then size.
- 1Aicore BulgariaSofia0 lines0 registrationssize 9.7
- 2AldenaPlovdiv0 lines0 registrationssize 9.7
- 3Aqua Lens EOODSofia0 lines0 registrationssize 9.7
- 4AQUACHIM 2020 Ltd.SOFIA0 lines0 registrationssize 9.7
- 5AromaniaSofia0 lines0 registrationssize 9.7
- 6Chimtex LtdDimitrovgrad0 lines0 registrationssize 9.7
- 7Dans Pharma Ltd.Sofia0 lines0 registrationssize 9.7
- 8Dentera LtdSofia0 lines0 registrationssize 9.7
- 9Dentstore BulgariaSofia0 lines0 registrationssize 9.7
- 10Dinamic Comfort EOODRuse, Nikolovo0 lines0 registrationssize 9.7
- 11DINI OTSVarna0 lines0 registrationssize 9.7
- 12Dorna EOODkazanlak0 lines0 registrationssize 9.7
- 13E.M.23-Konsident LtdSofia0 lines0 registrationssize 9.7
- 14ECOS Medica Ltd.София0 lines0 registrationssize 9.7
- 15EliT Medical Ltd.Sofia0 lines0 registrationssize 9.7
- 160 lines0 registrationssize 9.7
- 17Eternalize Medical LTDPlovdiv0 lines0 registrationssize 9.7
- 18FOT LTDSofia0 lines0 registrationssize 9.7
- 19GODE LIV Ltd.SOFIA0 lines0 registrationssize 9.7
- 20Helmed Bulgaria EOODSofia0 lines0 registrationssize 9.7
Include manufacturers, their own sales entities and regulatory representatives (107)
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.
- 1BTL Industries JSCSofia0 lines1 registrationsize 36.2
- 2Apyx Bulgaria Ltd.Sofia0 lines1 registrationsize 32.6
- 30 lines1 registrationsize 26.7
- 4KENTAMED Ltd.Plovdiv0 lines0 registrationssize 11.9
- 5Medray Ltd.Mramor (village)0 lines0 registrationssize 11.9
- 6Sopharma Trading ADSofia0 lines0 registrationssize 11.9
- 7STS Medical Group EADSandanski0 lines0 registrationssize 11.9
- 8Билк ЕООДВраца0 lines0 registrationssize 11.9
- 90 lines0 registrationssize 11.9
- 10Diachim EADSofia0 lines0 registrationssize 11.9
- 11Bul Med Consult LtdSofia0 lines0 registrationssize 9.7
- 12Diamed Ltd.Sofia0 lines0 registrationssize 9.7
- 13Endo Ltd.Varna0 lines0 registrationssize 9.7
- 14EURO MEDICAL GROUPSofia0 lines0 registrationssize 9.7
- 150 lines0 registrationssize 9.7
- 160 lines0 registrationssize 9.7
- 17MacmedSofia0 lines0 registrationssize 9.7
- 180 lines0 registrationssize 9.7
- 19Medical Express JSCSofia0 lines0 registrationssize 9.7
- 20MEDILINK 2001 Ltd.VARNA0 lines0 registrationssize 9.7
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By segment
| Segment | Establishments | |
|---|---|---|
| Surgery and endoscopy | 5 | Find distributors for your device |
| Orthopaedics, spine and trauma | 1 | Find distributors for your device |
| Cardiovascular | 3 | Find distributors for your device |
| Ear, nose and throat | 2 | Find distributors for your device |
| Gastroenterology, urology and OB/GYN | 5 | Find distributors for your device |
| Dental | 1 | Find distributors for your device |
| Anaesthesia and respiratory | 1 | Find distributors for your device |
| Patient monitoring and neurology | 4 | Find distributors for your device |
| Ophthalmic | 1 | Find distributors for your device |
| In-vitro diagnostics | 1 | Find distributors for your device |
| General hospital and consumables | 4 | Find distributors for your device |
| Aesthetics, dermatology and lasers | 2 | Find distributors for your device |
| Imaging, radiology and radiotherapy | 2 | Find distributors for your device |
| No segment in the registry record | 194 |
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.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 147 | 71% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Authorised representative | 4 | 2% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Manufacturer | 67 | 32% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 2 | 1% | 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 Bulgaria
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 Next 10 Markets report covers who holds the registration in each of your ten markets.
Questions about medical device distributors in Bulgaria
How many medical device distributors are there in Bulgaria?
The Index counts 207 medical device establishments registered in Bulgaria, of which 100 are independent distributors: importers, distributors, wholesalers or authorised representatives that do not manufacture themselves and are not a manufacturer's own sales company. The rest are manufacturers or their own sales entities. The number comes from EUDAMED, US FDA (openFDA) and MHRA UK and was last refreshed on 23 October 2026.
Who can hold a medical device registration in Bulgaria?
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 Bulgaria?
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 Bulgaria to see the counts for your segment and 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 a distributor in Bulgaria?
An establishment is a company that appears in a public regulatory registry with an address in Bulgaria, 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 contact people are collected.
Related markets in EU and EEA
Sources
- EUDAMED economic operator registration, European Commission public API: 197 establishments, last seen 23 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 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 7 establishments, last seen 23 October 2026. Public register.
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.