Identity
- Trade Name
- 25G VITRECTOMY KIT 2W FES EUDAMED
- Device Name
- 27G VITRECTOMY KIT ST 2W FES EUDAMED
- Model / Reference
- 193503 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059308006520 EUDAMED
- Basic UDI-DI
- 8059308KIT_VIT_044LZ EUDAMED
- EMDN Code
- Q021113 OPHTHALMIC SURGERY INSTRUMENT KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
25g Vitrectomy Kit 2w Fes by Optikon 2000 S.p.A. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8059308KIT_VIT_044LZ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Optikon 2000 S.p.A.
- EUDAMED SRN
- IT-MF-000017618
Sources (1)
- EUDAMED f13ede20-db39-4757-adef-3304c7873248 61 fields · synced Jul 14, 2026