Home › Türkiye › OPİA İNOVASYON SAĞLIK MEDİKAL ARGE VE DANIŞMANLIK SAN. DIŞ TİC. A.Ş.
Manufacturer of medical devices registered in the European database in Gaziantep, Türkiye.
| Registration number (SRN) | TR-MF-000021222 |
|---|---|
| Short name | Opia Health Medical |
| Role | Manufacturer |
| Status | Active |
| Country | Türkiye |
| City | 27090 Gaziantep |
| Address | İNCİLİ PINAR MAH. 36006 NOLU CAD. KEPKEP PLAZA BLOK NO: 20 İÇ KAPI NO: 29 ŞEHİTKAMİL / GAZİANTEP / TURKEY, 27090 Gaziantep |
| Registered on | 2022-03-10 |
| FDA establishment register | Not found in the U.S. FDA register |
|---|
⚠️ Not found is not the same as not registered. The two registers share no common identifier; the comparison is made on company names. This manufacturer may reach the United States through a distributor, or be registered under a name we could not match. State of the FDA register on 2026-08-20.
| Certificate | Status | Expiry | Type | Body |
|---|---|---|---|---|
M.2022.MDR.1002 | withdrawn | 2027-05-10 | Quality assurance | NB 2696 |
⚠️ State of the register on 2026-08-20. EUDAMED shows only the current version of a certificate — earlier versions are not published, by the Commission or by anyone. A certificate shown as valid here may have changed since. For a legally binding check, consult EUDAMED directly.
The SRN is the registration number assigned by the European Commission. It has been mandatory since 28 May 2026 for any operator placing a medical device on the Union market. Contact details are published in the official register; we do not reproduce them here.
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