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25g Vitrectomy Kit Sc Ch
EUDAMEDClass IIb (EU MDR)
Ref 193560Ref 193530Ref 193500
Identity
- Trade Name
- 25G VITRECTOMY KIT SC CH EUDAMED25G VITRECTOMY KIT SC EUDAMED25G VITRECTOMY KIT EUDAMED
- Device Name
- 27G VITRECTOMY KIT ST 2W FES EUDAMED
- Model / Reference
- 193560 EUDAMED193530 EUDAMED193500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059308007091 EUDAMED08059308006797 EUDAMED08059308006490 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 Ch 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 (3)
- EUDAMED f4ef707f-ebb5-4afa-8bcf-c71f6588b9f3 61 fields · synced Jul 22, 2026
- EUDAMED a8cafb10-dd6a-4c8b-9771-72f90ba6922b 61 fields · synced May 17, 2026
- EUDAMED d4cde184-de47-4756-8155-cb1d71c48461 61 fields · synced May 19, 2026