Identity
- Trade Name
- SILKO-CATH (3-WAY) EUDAMED
- Device Name
- Foley Balloon Catheter (Silicone) EUDAMED
- Model / Reference
- GS-1079 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265107913 EUDAMED08907265107944 EUDAMED08907265107920 EUDAMED
- Basic UDI-DI
- 8907265A015YE 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
No
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
Silko-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 | 8907265A015YE | 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 (3)
- EUDAMED 04dea2e2-d1f7-4f2f-891d-f865cc870c41 61 fields · synced Jul 24, 2026
- EUDAMED 69638160-d31f-401b-aab2-d31942a915cd 61 fields · synced May 17, 2026
- EUDAMED a78ff6c2-a30d-4fc0-abae-d2845b9d808f 61 fields · synced May 17, 2026