← Back to catalogue
Foley Trac (2 Way)
EUDAMEDClass IIa (EU MDR)
Ref GS 1026 KADRef GS 1026Ref GS 1022
Identity
- Trade Name
- FOLEY TRAC (2 WAY) EUDAMED
- Device Name
- Foley Balloon Catheter (Latex) EUDAMED
- Model / Reference
- GS 1026 KAD EUDAMEDGS 1026 EUDAMEDGS 1022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265010800 EUDAMED08907265102628 EUDAMED08907265102611 EUDAMED08907265102215 EUDAMED08907265010787 EUDAMED08907265102635 EUDAMED08907265102666 EUDAMED08907265010794 EUDAMED08907265102659 EUDAMED08907265010770 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 (2 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 (10)
- EUDAMED 194403c3-5e79-44f4-8461-c895f39b7594 61 fields · synced Oct 6, 2026
- EUDAMED f306e596-48c3-4430-9a23-378c67bcb264 61 fields · synced May 16, 2026
- EUDAMED 3c7ec87a-598b-4d3b-9c0a-f44729c3a2d7 61 fields · synced May 16, 2026
- EUDAMED a4d3ed4a-6600-4252-82ce-45a9a545f7ea 61 fields · synced May 17, 2026
- EUDAMED cba8b3e6-64a8-46c7-b773-f1a69ec9636b 61 fields · synced May 17, 2026
- EUDAMED 221340cc-02ab-49d5-a4bf-ea84fb6e7d1f 61 fields · synced May 17, 2026
- EUDAMED c98f3853-8819-4c16-9d04-3dc061461778 61 fields · synced May 19, 2026
- EUDAMED 674ffea3-16fd-4928-9489-845937d95e17 61 fields · synced May 19, 2026
- EUDAMED 808ff65c-02e3-4243-afa9-11e6a11815b0 61 fields · synced May 19, 2026
- EUDAMED 4560da77-3723-489e-bb22-7078d3e4996e 61 fields · synced May 19, 2026