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Tubing set Faros/CataRhex 3/Swisstech
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref VV621003Model MD0105.102 Tubing Sets Single Pump System ReusableRef VV621010Model MD0105.02 Tubing Sets Single Pump System Single Use
Identity
- Trade Name
- Tubing set Faros/CataRhex 3/Swisstech EUDAMEDOertli® FDA UDI
- Generic Name
- Surgical irrigation/aspiration tubing set FDA UDI
- Device Name
- I/A TUBING SYSTEM FOR FAROS/; CR3/SWISSTECH; FDA UDI
- Model / Reference
- MD0105.102 Tubing Sets Single Pump System Reusable EUDAMEDVV621003 EUDAMEDMD0105.02 Tubing Sets Single Pump System Single Use EUDAMEDVV621010 EUDAMEDFDA UDI
- Description
- I/A TUBING SYSTEM FOR FAROS/; CR3/SWISSTECH; FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630003904376 EUDAMED07630003904390 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300039MD0105102UX EUDAMED76300039MD010502SY EUDAMED
- Direct Marketing DI
- 07630003904376 EUDAMED
- FDA Product Code
- HQC FDA UDI
- EMDN Code
- Q020499,Q020699 EUDAMED
- GMDN Term
- Surgical irrigation/aspiration tubing set 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
No
EUDAMEDEUDAMEDFDA 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
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 | 76300039MD0105102UX | 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 (3)
- EUDAMED e3c4d9d9-1c2e-481a-b525-441c52d07abd 61 fields · synced Jul 11, 2026
- EUDAMED c90174b9-a61e-4b20-9a6a-ad1571e9095d 61 fields · synced May 18, 2026
- FDA UDI c9d028de-468a-48fc-82b2-c40e86b64888 34 fields · synced May 30, 2026