Identity
- Device Name
- Latex Foley Catheter EUDAMED
- Model / Reference
- 20109 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051400201097 EUDAMED
- Basic UDI-DI
- B-05051400201097 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
Yes
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
Latex 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-05051400201097 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Curas Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000036883
- Authorised Representative
- Kabomed GmbH AT-AR-000007569
Sources (1)
- EUDAMED 275c282a-c22c-469d-8484-36fa75e05f1e 61 fields · synced Jul 23, 2026