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Vitrectomy pack Faros 25G
EUDAMEDClass IIa (EU MDR)
Ref VV621215BPModel MD0105.16 Vitrectomy Packs Faros Single Use
Identity
- Trade Name
- Vitrectomy pack Faros 25G EUDAMED
- Model / Reference
- MD0105.16 Vitrectomy Packs Faros Single Use EUDAMEDVV621215BP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630003912968 EUDAMED
- Basic UDI-DI
- 76300039MD010516TB EUDAMED
- EMDN Code
- Q020402 POSTERIOR VITRECTOMY SETS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Vitrectomy pack Faros 25G by Oertli Instrumente Ag — Class IIa — 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 | 76300039MD010516TB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Oertli Instrumente AG
- EUDAMED SRN
- CH-MF-000016175
- Authorised Representative
- Oertli Ophthalmedic Österreich GmbH AT-AR-000003554
Sources (1)
- EUDAMED e5573a56-5961-4a6f-9884-219973e430f7 61 fields · synced Jul 13, 2026