Identity
- Trade Name
- TEKNOMEK EUDAMED
- Device Name
- Pediatric Eye Speculum (Large) EUDAMED
- Model / Reference
- AS412A1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680548914117 EUDAMED
- Basic UDI-DI
- B-08680548914117 EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Teknomek by TEKNOMEK MEDİKAL MALZEMELERİ SAN. ve TİC. LTD. ŞTİ. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08680548914117 | Class IIa | Active |
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Manufacturer
- Manufacturer
- TEKNOMEK MEDİKAL MALZEMELERİ SAN. ve TİC. LTD. ŞTİ.
- EUDAMED SRN
- TR-MF-000018462
Sources (1)
- EUDAMED 96a2d774-b88f-4f30-8fd9-146c5152cc33 61 fields · synced Jun 18, 2026