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Phaco pack Faros/CR3/Swisstech, 2.2 MM
EUDAMEDClass IIa (EU MDR)
Ref VV621011DEC2Model MD0105.12 Surgery Packs Faros CataRhex Family Single Use
Identity
- Trade Name
- Phaco pack Faros/CR3/Swisstech, 2.2 MM EUDAMED
- Model / Reference
- MD0105.12 Surgery Packs Faros CataRhex Family Single Use EUDAMEDVV621011DEC2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630003918984 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, 2.2 MM 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 c5e760f4-f646-40fb-a6dd-168ce116edd8 61 fields · synced Jun 19, 2026