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Phaco pack Faros/CR3/Swisstech, 2.2MM
EUDAMEDClass IIa (EU MDR)
Ref VV621011DEBModel MD0105.12 Surgery Packs Faros CataRhex Family Single Use
Identity
- Trade Name
- Phaco pack Faros/CR3/Swisstech, 2.2MM EUDAMED
- Model / Reference
- MD0105.12 Surgery Packs Faros CataRhex Family Single Use EUDAMEDVV621011DEB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630003911107 EUDAMED
- Basic UDI-DI
- 76300039MD010512T3 EUDAMED
- EMDN Code
- Q020601 PHACOEMULSIFICATION 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
Phaco pack Faros/CR3/Swisstech, 2.2MM 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 | 76300039MD010512T3 | 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 fcbf4351-8cb5-45c4-a15e-83ee98f4f089 61 fields · synced Jun 19, 2026