Identity
- Trade Name
- URETHRAL CATHETER EUDAMED
- Device Name
- Foley Balloon Catheter (Latex) EUDAMEDNELATON CATHETER EUDAMED
- Model / Reference
- GS-1012R EUDAMEDGS-1012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265000450 EUDAMED08907265101218 EUDAMED08907265000535 EUDAMED08907265101287 EUDAMED08907265101256 EUDAMED08907265000498 EUDAMED08907265000474 EUDAMED08907265101249 EUDAMED08907265101263 EUDAMED08907265000467 EUDAMED08907265101270 EUDAMED08907265101294 EUDAMED08907265101225 EUDAMED08907265000481 EUDAMED08907265000504 EUDAMED08907265003086 EUDAMED
- Basic UDI-DI
- 8907265A010Y4 EUDAMED8907265A002Y5 EUDAMED
- EMDN Code
- U010101 URETHRAL PROSTATIC AND BLADDER CATHETERS, CONICAL-OLIVARY TIP (URETHRAL CALIBRATION) EUDAMEDU01010502 NELATON CATHETERS, NON SELF-LUBRICATING 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
EUDAMEDEUDAMED
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 (16)
- EUDAMED 404b2fa8-c9b9-4e57-9457-95969da3ed32 61 fields · synced Jul 30, 2026
- EUDAMED 7593f85a-ad8d-4227-927a-d1d6dcbb49a9 61 fields · synced May 17, 2026
- EUDAMED f04a3152-71c2-4d16-aa3f-7c9615e72c32 61 fields · synced May 17, 2026
- EUDAMED feca2265-6647-4266-bece-b393a9e3d8bf 61 fields · synced May 17, 2026
- EUDAMED 3d4bdc05-c759-4490-90f1-44573813ef56 61 fields · synced May 17, 2026
- EUDAMED 48c2d6b1-3ec8-488c-8c6a-ff110beddefb 61 fields · synced May 17, 2026
- EUDAMED 5775364a-1ce8-444e-a6c5-4ced78d69a9b 61 fields · synced May 17, 2026
- EUDAMED 5f42731f-4ec5-4d4a-87ea-9cf1275203e8 61 fields · synced May 18, 2026
- EUDAMED e49c7e42-6fb8-45c3-9080-bb7451d57740 61 fields · synced May 18, 2026
- EUDAMED ca00f537-9f80-4449-8bc0-35a3d23d8e03 61 fields · synced May 19, 2026
- EUDAMED 2101944b-334c-404c-ab6a-66c49e317a46 61 fields · synced May 19, 2026
- EUDAMED 6433f2ca-57bf-4b21-8387-6d70a6331237 61 fields · synced May 19, 2026
- EUDAMED aa981255-3c45-44b7-96e5-760671619b72 61 fields · synced May 19, 2026
- EUDAMED 5156e20e-e2a6-4323-88db-1491604297be 61 fields · synced May 19, 2026
- EUDAMED 97672822-d991-42e8-8a68-bff94b03c074 61 fields · synced May 19, 2026
- EUDAMED d5d5f49e-5e8d-4c54-b45b-a04ad2994b70 61 fields · synced Jul 9, 2026