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Foley Balloon Catheter (Cathtec)
EUDAMEDClass IIa (EU MDR)
Ref 1733.FL08.20FRModel FB2
Identity
- Trade Name
- Foley Balloon Catheter (Cathtec) EUDAMED
- Device Name
- Foley Balloon Catheter (Latex) EUDAMED
- Model / Reference
- FB2 EUDAMED1733.FL08.20FR EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G4011733FL0820FR0/$$331083126CD0410 EUDAMED
- Basic UDI-DI
- ++G401FBCPQ EUDAMED
- EMDN Code
- U040203 NEPHROSTOMY CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Foley Balloon Catheter (Cathtec) by Disposafe Health & Lifecare Limited — 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 | ++G401FBCPQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Disposafe Health & Lifecare Limited
- EUDAMED SRN
- IN-MF-000020265
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED b99eff95-3486-411d-805a-986851e89122 61 fields · synced Sep 30, 2026