Identity
- Trade Name
- TEKNOMEK EUDAMED
- Device Name
- Bimanuel I / A Sets (21G irrigation / 23G aspiration) EUDAMED
- Model / Reference
- CAC280P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680548915916 EUDAMED
- Basic UDI-DI
- B-08680548915916 EUDAMED
- EMDN Code
- Q021101 OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE 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
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Teknomek by TEKNOMEK MEDİKAL MALZEMELERİ SAN. ve TİC. LTD. ŞTİ. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use.
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- SURGISTAR — Surgistar Inc. · Class I
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-08680548915916 | 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 d7931f8b-3c2b-4bd6-81f8-63f9fe2a42eb 61 fields · synced Jun 19, 2026