Identity
- Trade Name
- HYOTEK EUDAMED
- Device Name
- "Sterile viscoelastic solution – Sodium Hyaluronate - Hyotek 2.4% 1.5ml" EUDAMED
- Model / Reference
- CT24V15M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680548916432 EUDAMED
- Basic UDI-DI
- B-08680548916432 EUDAMED
- EMDN Code
- Q02030399 OPHTHALMOLOGY, VISCOELASTIC FLUIDS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Hyotek by TEKNOMEK MEDİKAL MALZEMELERİ SAN. ve TİC. LTD. ŞTİ. — Class IIb — 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-08680548916432 | Class IIb | Active |
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Manufacturer
- Manufacturer
- TEKNOMEK MEDİKAL MALZEMELERİ SAN. ve TİC. LTD. ŞTİ.
- EUDAMED SRN
- TR-MF-000018462
Sources (1)
- EUDAMED 0cf320a8-12c4-4240-b908-84b18da47049 61 fields · synced Jun 18, 2026