Updated 22 October 2026
Medical device distributors in Bulgaria: 160 licensed establishments
The Bastion Hale Distributor Index lists 160 medical device establishments registered with an address in Bulgaria: 116 with a channel role (importer, distributor, wholesaler or authorised representative), 0 registration holders without a channel role, and 44 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 | 5 | Search in the Index |
| Orthopaedics, spine and trauma | 1 | Search in the Index |
| Cardiovascular | 3 | Search in the Index |
| Ear, nose and throat | 2 | Search in the Index |
| Gastroenterology, urology and OB/GYN | 5 | Search in the Index |
| Dental | 1 | Search in the Index |
| Anaesthesia and respiratory | 1 | Search in the Index |
| Patient monitoring and neurology | 4 | Search in the Index |
| Ophthalmic | 1 | Search in the Index |
| In-vitro diagnostics | 1 | Search in the Index |
| General hospital and consumables | 4 | Search in the Index |
| Aesthetics, dermatology and lasers | 2 | Search in the Index |
| Imaging, radiology and radiotherapy | 2 | Search in the Index |
| No segment in the registry record | 147 |
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 | 113 | 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 | 53 | 33% | 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 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 | BTL Industries JSC Sofia | Channel Importer, Manufacturer | Aesthetics, dermatology and lasers, Gastroenterology, urology and OB/GYN, Patient monitoring and neurology +1 more | 31 | 1 | 0 | 36.2 | 3/5 |
| 2 | Apyx Bulgaria Ltd. Sofia | Channel Importer, Manufacturer | Aesthetics, dermatology and lasers, Surgery and endoscopy | 15 | 1 | 0 | 32.6 | 4/5 |
| 3 | Cocoon Medical International, Ltd Sofia | Channel Importer, Manufacturer | Surgery and endoscopy | 4 | 1 | 0 | 26.7 | 4/5 |
| 4 | KENTAMED Ltd. Plovdiv | Channel Importer, Manufacturer | No segment in record | 0 | 0 | 0 | 11.9 | 2/5 |
| 5 | Medray Ltd. Mramor (village) | Channel Importer, Manufacturer | No segment in record | 0 | 0 | 0 | 11.9 | 2/5 |
| 6 | Sopharma Trading AD Sofia | Channel Importer, Manufacturer | No segment in record | 0 | 0 | 0 | 11.9 | 2/5 |
| 7 | STS Medical Group EAD Sandanski | Channel Importer, Manufacturer | No segment in record | 0 | 0 | 0 | 11.9 | 2/5 |
| 8 | Медицинска Техника Инженеринг ООД София | Channel Importer, Manufacturer | No segment in record | 0 | 0 | 0 | 11.9 | 2/5 |
| 9 | Compliance Management Solutions Europe LTD Petrich | Channel Importer, Authorised representative | No segment in record | 0 | 0 | 0 | 11.9 | 1/5 |
| 10 | Diachim EAD Sofia | Channel Importer, Manufacturer | No segment in record | 0 | 0 | 0 | 11.9 | 1/5 |
| 11 | Aicore Bulgaria Sofia | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 12 | Aldena Plovdiv | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 13 | Aqua Lens EOOD Sofia | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 14 | AQUACHIM 2020 Ltd. SOFIA | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 15 | Aromania Sofia | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 16 | Bul Med Consult Ltd Sofia | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 17 | Chimtex Ltd Dimitrovgrad | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 18 | Dans Pharma Ltd. Sofia | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 19 | Dentera Ltd Sofia | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 20 | Dentstore Bulgaria Sofia | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
Questions about medical device distributors in Bulgaria
How many medical device distributors are there in Bulgaria?
The Index counts 160 medical device establishments registered in Bulgaria, of which 116 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 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 reveal three profiles. For a ranked shortlist for your device, get 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 contacts or named individuals are collected.
Related markets in EU and EEA
Sources
- EUDAMED economic operator registration, European Commission public API: 153 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.