Identity
- Trade Name
- URO CATH (2 WAY) EUDAMED
- Device Name
- Foley Balloon Catheter (Latex) EUDAMED
- Model / Reference
- GS 1072 EUDAMEDGS 1090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265107234 EUDAMED08907265109023 EUDAMED08907265109016 EUDAMED08907265107258 EUDAMED08907265107203 EUDAMED08907265107241 EUDAMED08907265107210 EUDAMED08907265107265 EUDAMED
- Basic UDI-DI
- 8907265A010Y4 EUDAMED
- EMDN Code
- U010299 URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER 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
Category: Indwelling urethral drainage balloon catheter, non-antimicrobial
Uro Cath (2 Way) by Romsons Group Private Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.
- Sunmed — SunMed · Class II
- Dover — Cardinalhealth · Class II
- Silicone Foley Catheters — Dynarex Corp. · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- Porges Coloplast — Coloplast A/S · Class II
- Latex Foley Catheter — Well Lead Medical Co., Ltd · Class II
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 (8)
- EUDAMED f47ef923-213c-43ad-85a2-30b2afc9cb6e 61 fields · synced Aug 3, 2026
- EUDAMED 3ba07a6b-d189-4c54-8143-ad5d811a8634 61 fields · synced May 16, 2026
- EUDAMED 3797d34d-1d56-49c3-a414-9cd575f2e0c6 61 fields · synced May 17, 2026
- EUDAMED c9fc7d6d-32ea-47f0-84c7-0a1f7d41baff 61 fields · synced May 17, 2026
- EUDAMED 0eb69a10-c383-4886-bcb8-d799eb62e965 61 fields · synced May 17, 2026
- EUDAMED 5b0af2d4-f56d-4511-8ca8-84dafb085afa 61 fields · synced May 17, 2026
- EUDAMED 067032bb-f8fc-42ef-a7eb-e1286219a237 61 fields · synced May 19, 2026
- EUDAMED 66925af2-ffcd-4994-a10c-479ef445b332 61 fields · synced May 19, 2026