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Phaco pack Faros/CR3/Swisstech CO-MICS
EUDAMEDClass IIa (EU MDR)
Ref VV621111CEA2Model MD0105.12 Surgery Packs Faros CataRhex Family Single UseRef VV621111CEA
Identity
- Trade Name
- Phaco pack Faros/CR3/Swisstech CO-MICS EUDAMED
- Model / Reference
- MD0105.12 Surgery Packs Faros CataRhex Family Single Use EUDAMEDVV621111CEA2 EUDAMEDVV621111CEA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630003914795 EUDAMED07630003911305 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 CO-MICS 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 (2)
- EUDAMED c9a18944-6038-4121-a107-b5f6954c4673 61 fields · synced Jul 28, 2026
- EUDAMED b962b4c7-50ee-4d04-ac49-9a13724d36c1 61 fields · synced May 17, 2026