Identity
- Trade Name
- SILKO-CATH (2-WAY) EUDAMED
- Device Name
- Foley Balloon Catheter (Silicone) EUDAMED
- Model / Reference
- GS-1078 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265107890 EUDAMED08907265107814 EUDAMED08907265107869 EUDAMED08907265107845 EUDAMED08907265107876 EUDAMED08907265107807 EUDAMED08907265107838 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 EUDAMEDBelgium 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 (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 | 8907265A015YE | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Romsons Group Private Limited
- EUDAMED SRN
- IN-MF-000036506
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (7)
- EUDAMED 4e32436c-3802-47c1-a61d-2c53f55df144 61 fields · synced Oct 5, 2026
- EUDAMED a57916e8-4f70-4676-9552-a79d6ad29347 61 fields · synced May 16, 2026
- EUDAMED c56acf25-7d07-4496-991e-b339da17a6fe 61 fields · synced May 16, 2026
- EUDAMED 9ae2b518-0ab8-4840-a558-3b1fb327cf10 61 fields · synced May 17, 2026
- EUDAMED 5bde9e12-a66c-44f8-a0ac-b2a7b6897199 61 fields · synced May 19, 2026
- EUDAMED d3215b58-856a-418d-a3c0-43b1b563f956 61 fields · synced May 19, 2026
- EUDAMED d37217c2-e144-4eab-b96f-71c6d2cce484 61 fields · synced May 19, 2026