Identity
- Trade Name
- 23G VITRECTOMY KIT SC EUDAMED23G VITRECTOMY KIT SC FES EUDAMED
- Device Name
- 27G VITRECTOMY KIT ST 2W FES EUDAMED
- Model / Reference
- 193330 EUDAMED193332 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059308005691 EUDAMED08059308005714 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
23g Vitrectomy Kit Sc 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 (2)
- EUDAMED fbbbd2b7-ade8-4c50-bc08-5feb17e31b30 61 fields · synced Sep 17, 2026
- EUDAMED fd6e239a-e72c-441e-bab3-feb87fc95c6e 61 fields · synced May 19, 2026