Identity
- Trade Name
- Foley Balloon Catheter EUDAMED
- Device Name
- Foley Balloon Catheter (Latex) EUDAMED
- Model / Reference
- FB2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- FBCP EUDAMED
- Basic UDI-DI
- ++G401FBCPQ EUDAMED
- Direct Marketing DI
- FBCP EUDAMED
- EMDN Code
- U040203 NEPHROSTOMY CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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 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 0fb9c3fb-dfad-4608-876b-a78e64da03b6 61 fields · synced Jul 25, 2026