Identity
- Trade Name
- 23G VITRECTOMY PROBE EUDAMED
- Device Name
- 27G Twedge high speed dual blade vitrectomy probe EUDAMED
- Model / Reference
- 192303 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059308002478 EUDAMED
- Basic UDI-DI
- 8059308SUR_ACC_030JE EUDAMED
- EMDN Code
- Q020499 VITRECTOMY DEVICES - OTHER 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 Probe 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 | 8059308SUR_ACC_030JE | Class IIb | Active |
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Manufacturer
- Manufacturer
- Optikon 2000 S.p.A.
- EUDAMED SRN
- IT-MF-000017618
Sources (1)
- EUDAMED b64ff562-55f8-4113-993c-7fe9ea37f2c3 61 fields · synced Jul 10, 2026