Identity
- Trade Name
- URO CATH (3 WAY) EUDAMED
- Device Name
- Foley Balloon Catheter (Latex) EUDAMED
- Model / Reference
- GS 1094 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265109405 EUDAMED08907265109429 EUDAMED08907265109443 EUDAMED08907265109436 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 (3 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 (4)
- EUDAMED 6291cae2-15cb-44d2-b407-7a593d4df3d2 61 fields · synced Aug 4, 2026
- EUDAMED 83de11d9-bf1e-4cc1-850f-7ca0da06f8c7 61 fields · synced May 17, 2026
- EUDAMED ca61d2a8-5510-49bd-962d-a83ef28137fb 61 fields · synced May 17, 2026
- EUDAMED 4e91006d-819f-430d-b6b2-e472a7995273 61 fields · synced May 19, 2026