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Tubing set Faros/CataRhex 3/Swisstech
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref VV621010AModel MD0105.02 Tubing Sets Single Pump System Single Use
Identity
- Trade Name
- Tubing set Faros/CataRhex 3/Swisstech EUDAMEDOertli® FDA UDI
- Generic Name
- Phacoemulsification system FDA UDI
- Device Name
- I/A TUBING SYSTEM FOR FAROS/; CR3/SWISSTECH, INCL. INFUSION; SET, DRAINAGE BAG, PE-BAG FDA UDI
- Model / Reference
- MD0105.02 Tubing Sets Single Pump System Single Use EUDAMEDVV621010A EUDAMEDFDA UDI
- Description
- I/A TUBING SYSTEM FOR FAROS/; CR3/SWISSTECH, INCL. INFUSION; SET, DRAINAGE BAG, PE-BAG FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630003909685 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300039MD010502SY EUDAMED
- FDA Product Code
- HQC FDA UDI
- EMDN Code
- Q020499,Q020699 EUDAMED
- GMDN Term
- Phacoemulsification system 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Tubing set Faros/CataRhex 3/Swisstech 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 | 76300039MD010502SY | 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 3d5e13d2-9f7b-4cbb-acdc-221aba7f3909 61 fields · synced Jul 9, 2026
- FDA UDI f673b2c8-928f-43c4-b959-7ef27be72b90 34 fields · synced May 30, 2026