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Phaco pack Faros/CR3/Swisstech, 2.2 MM
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref VV621011DECModel MD0105.12 Surgery Packs Faros CataRhex Family Single Use
Identity
- Trade Name
- Phaco pack Faros/CR3/Swisstech, 2.2 MM EUDAMEDOertli® FDA UDI
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- PHACO PACK FAROS/CR3/SWISSTECH; SLEEVE (FOR EASYTIP 2.2MM),; TEST CHAMBER, TUBING SYSTEM FDA UDI
- Model / Reference
- MD0105.12 Surgery Packs Faros CataRhex Family Single Use EUDAMEDVV621011DEC EUDAMEDFDA UDI
- Description
- PHACO PACK FAROS/CR3/SWISSTECH; SLEEVE (FOR EASYTIP 2.2MM),; TEST CHAMBER, TUBING SYSTEM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630003915709 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300039MD010512T3 EUDAMED
- FDA Product Code
- HQC FDA UDI
- EMDN Code
- Q020601 PHACOEMULSIFICATION SETS EUDAMED
- GMDN Term
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4670 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Phaco pack Faros/CR3/Swisstech, 2.2 MM by Oertli Instrumente Ag — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76300039MD010512T3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 8449b7ec-e47e-4a9b-8621-1a981d9c01d5 61 fields · synced Jun 18, 2026
- FDA UDI 31e6da89-9d55-479b-8ff3-cdf4c15a21e9 33 fields · synced May 30, 2026