Identity
- Trade Name
- 25G VITRECTOMY KIT SC FES EUDAMED25G VITRECTOMY KIT SC CH FES EUDAMED
- Device Name
- 27G VITRECTOMY KIT ST 2W FES EUDAMED
- Model / Reference
- 193532 EUDAMED193562 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059308006810 EUDAMED08059308007114 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 Sc 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 (2)
- EUDAMED 2c37fba1-e6aa-4930-a4a3-3c734f4134e3 61 fields · synced Aug 1, 2026
- EUDAMED 1d06627f-e0c0-469f-8673-8ff3cc6882bd 61 fields · synced May 19, 2026