Identity
- Device Name
- 100% Silicone Foley Catheter EUDAMED
- Model / Reference
- 20001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051400200014 EUDAMED
- Basic UDI-DI
- B-05051400200014 EUDAMED
- EMDN Code
- U010201 URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON 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
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
100% Silicone Foley Catheter by Curas Sdn. Bhd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05051400200014 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Curas Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000036883
- Authorised Representative
- Kabomed GmbH AT-AR-000007569
Sources (1)
- EUDAMED 3d18f908-5a7f-40fa-924e-25fcbd69a3a8 61 fields · synced Jul 19, 2026