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Foley Balloon Catheter
EUDAMEDClass IIa (EU MDR)
Ref 30178Model Foley Balloon Catheter
Identity
- Trade Name
- Foley Balloon Catheter EUDAMED
- Device Name
- Foley Balloon Catheter EUDAMED
- Model / Reference
- Foley Balloon Catheter EUDAMED30178 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095301784 EUDAMED
- Basic UDI-DI
- 890209530303E9 EUDAMED
- EMDN Code
- U020202 URETERAL CATHETERS WITH FLUTE TIP WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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 Poly Medicure 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 | 890209530303E9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Poly Medicure Limited
- EUDAMED SRN
- IN-MF-000043009
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 9e761964-5c9d-4afc-aa99-aa7eb3be1b49 61 fields · synced Aug 4, 2026