Identity
- Trade Name
- URETHRAL CATHETER EUDAMED
- Device Name
- Foley Balloon Catheter (Latex) EUDAMED
- Model / Reference
- GS-1012R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265000528 EUDAMED
- Basic UDI-DI
- 8907265A010Y4 EUDAMED
- EMDN Code
- U010101 URETHRAL PROSTATIC AND BLADDER CATHETERS, CONICAL-OLIVARY TIP (URETHRAL CALIBRATION) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Urethral Catheter by Romsons Group Private 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 | 8907265A010Y4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Romsons Group Private Limited
- EUDAMED SRN
- IN-MF-000036506
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED cac152cf-d796-4fe8-8a45-5b597fb15be3 61 fields · synced Jun 19, 2026