Identity
- Trade Name
- FOLEY TRAC (3 WAY) EUDAMED
- Device Name
- Foley Balloon Catheter (Latex) EUDAMED
- Model / Reference
- GS 1107 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265110739 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
Foley Trac (3 Way) 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 |
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 (1)
- EUDAMED a7f33296-716e-43e7-8ba8-8ff3755d16f0 61 fields · synced Jun 18, 2026