Updated 25 October 2026
Who holds medical device registrations in Türkiye
Under Türkiye's medical device regulation, a device whose manufacturer is not established in Türkiye or an EU member state can be placed on the market only once the manufacturer appoints an authorised representative. The Index lists 65 authorised representatives in Türkiye from the EUDAMED register, last read on 23 October 2026.
Medical device companies in Türkiye: distributors, importers and makers
General information, not legal advice. Local law varies; take local counsel.
Who may hold a registration in Türkiye
Under Türkiye's medical device regulation, a device whose manufacturer is not established in Türkiye or an EU member state can be placed on the market only once the manufacturer appoints an authorised representative.
The local term is yetkili temsilci.
The list comes from EUDAMED, where Turkish economic operators register as actors. Türkiye's own product tracking system (ÜTS) is not in the Index yet.
Sources: TİTCK announcement 2023/KK-6 (Tıbbi Cihaz Yönetmeliği, Article 11).
Authorised representatives in Türkiye: top 50
EUDAMED publishes no count of mandates per representative, so the list is ordered as on the country page: independent distributors first, then lines carried, registrations in other registries and size. Each name opens its profile with roles, principals and sources.
- 1Distributor
- 2Distributor
- 3Distributor
- 4Distributor
- 5Distributor
- 6Distributor
- 7Distributor
- 8Variteks Ortopedi Sanayi A.Ş.İstanbulMaker's own entity
- 9Response Ortho Teknolojik Üretim A.Ş.İstanbul, IstanbulMaker's own entity
- 10Maker's own entity
- 11STERAMED MEDİKAL LİMİTED ŞİRKETİGazi̇AntepMaker's own entity
- 12Maker's own entity
- 13Maker's own entity
- 14Maker's own entity
- 15Maker's own entity
- 16Maker's own entity
- 17Maker's own entity
- 18ORYX DIS TICARET LIMITED SIRKETIIstanbulMaker's own entity
- 19Maker's own entity
- 20Maker's own entity
- 21Maker's own entity
- 22Maker's own entity
- 23Maker's own entity
- 24Maker's own entity
- 25Maker's own entity
- 26Maker's own entity
- 27Maker's own entity
- 28Maker's own entity
- 29MEDİPRO İÇ VE DIŞ TİC. LTD. ŞTİ.İStanbulMaker's own entity
- 30Maker's own entity
- 31Maker's own entity
- 32Vision Biyoteknoloji Araştırma Geliştirme Laboratuvar Sistemleri Sanayi ve Ticaret Limited ŞirketiIstanbulMaker's own entity
- 33Maker's own entity
- 34Maker's own entity
- 35Maker's own entity
- 36Maker's own entity
- 37Maker's own entity
- 38Maker's own entity
- 39Maker's own entity
- 40Sanitas Teknoloji Tibbi cihazlar ve Tic. Ltd. Sti.Ümraniye IstanbulMaker's own entity
- 41SMS GROUP MEDIKAL SANAYI VE TICARET ANONIM SIRKETIBuyukcekmece- istanbul TurkeyMaker's own entity
- 42Maker's own entity
- 43fi medikal ltd.stiAnkaraMaker's own entity
- 44Maker's own entity
- 45Regulatory representative
- 46Regulatory representative
- 47Regulatory representative
- 48Regulatory representative
- 49Regulatory representative
- 50Regulatory representative
Download all 65 company rows as CSV
Company level only: names that are only a person's name are left out.
How many holders also distribute
7 of the 65 holders listed here (11%) are also independent distributors in the Index: companies that supply the market for makers other than themselves, not a manufacturer, a maker's own entity or a regulatory service firm.
The others: 37 makers' own import or sales entities and 21 regulatory representatives that hold registrations with no sign in the registries that they supply the market.
Holders that also distribute in Türkiye: top 7
- 1Distributor
- 2Distributor
- 3Distributor
- 4Distributor
- 5Distributor
- 6Distributor
- 7Distributor
See every independent distributor in Türkiye on the country page.
Independent holders in Türkiye: top 20
Companies that hold registrations here with no sign in the registries that they supply the market themselves: regulatory representatives and holders as a service. A holder that is not your distributor keeps your distributors replaceable. Confirm what each one does before you appoint it.
- 1Regulatory representative
- 2Regulatory representative
- 3Regulatory representative
- 4Regulatory representative
- 5Regulatory representative
- 6Regulatory representative
- 7Regulatory representative
- 8Regulatory representative
- 9Regulatory representative
- 10Regulatory representative
- 11Regulatory representative
- 12ALICE MEDIKAL SOSYAL HIZMETLER KIRTASIYE TASIMACILIK PETROL SANAYI TAAHÜT TICARET LIMITEDDi̇YarbakirRegulatory representative
- 13BASH MEDICAL LTD.ŞTIİStanbulRegulatory representative
- 14Regulatory representative
- 15Regulatory representative
- 16Regulatory representative
- 17Regulatory representative
- 18Regulatory representative
- 19Regulatory representative
- 20Regulatory representative
Medical device registration in Türkiye with CE or FDA clearance
With CE marking: CE marking is accepted as it is.
With FDA clearance: No reliance route on FDA clearance is confirmed in the source.
Regulation aligned with the EU MDR; CE certificate is the basis and a local importer or representative registers the device in UTS.
Sources: US International Trade Administration, Country Commercial Guide: Turkey medical technologies and health it. Confidence in this route: medium, checked 23 October 2026. Rules change and differ by device class; confirm with the regulator before you plan a launch date.
How to check it yourself in the official register
EUDAMED, actor registration (economic operators). Search the economic operators for an authorised representative with an address in Türkiye. Device records sit in the TİTCK product tracking system (ÜTS).
Also: TİTCK, product tracking system (ÜTS).
The register is the record that counts. Check the holder named on your own device's registration before you sign, and again before you change distributors.
What changes if you switch holder
The registration sits in the holder's name, not yours. If the holder is also your distributor, changing or adding a distributor means moving the registration or filing a new one, and where a regulator publishes a transfer process, the current holder has to take part.
Independent holders, firms that hold registrations for makers without selling their products, keep your distributors replaceable. In the Index, 21 of the companies listed here show no sign in the registries that they supply the market themselves, which is a place to start looking; confirm what each one does before you appoint it.
The article Who holds the registration compares holding it yourself, through an independent holder or through your distributor, and lists the clauses to agree before the first order.
Next step
Registration holders in Türkiye: questions
Who can be a registration holder in Türkiye?
Under Türkiye's medical device regulation, a device whose manufacturer is not established in Türkiye or an EU member state can be placed on the market only once the manufacturer appoints an authorised representative.
Can a distributor hold my registration in Türkiye?
In the Index, 7 of the 65 authorised representatives listed for Türkiye are also independent distributors. Whether your distributor should hold it is a separate decision, because the holder controls market access: see Who holds the registration.
Is there a list of authorised representatives?
Yes. This page lists the top 50 of the 65 authorised representatives the Index holds for Türkiye, each linked to its profile, and the CSV carries 65 company rows. The official record is the EUDAMED, actor registration (economic operators).
How do I check who holds a device registration in Türkiye?
Use the EUDAMED, actor registration (economic operators). Search the economic operators for an authorised representative with an address in Türkiye. Device records sit in the TİTCK product tracking system (ÜTS).
Sources
- EUDAMED economic operator registration, European Commission public API: 65 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: 1 establishment, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 1 establishment, last seen 23 October 2026. Public register.
Index build 25 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.