Identity
- Trade Name
- FLEXO CATH - RA EUDAMEDFLEXO CATH – RA EUDAMED
- Device Name
- THORACIC DRAINAGE CATHETER (CHEST DRAINAGE CATHETER) EUDAMED
- Model / Reference
- GS-5034 A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265000139 EUDAMED08907265001990 EUDAMED08907265503487 EUDAMED08907265000122 EUDAMED08907265503470 EUDAMED
- Basic UDI-DI
- 8907265G003ZH EUDAMED
- EMDN Code
- A0601010401 THORACIC DRAINAGES (STRAIGHT AND ANGLED) 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
Flexo Cath - Ra 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 | 8907265G003ZH | 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 (5)
- EUDAMED 3ede68f5-44af-46be-833a-9648a9a10870 61 fields · synced Oct 6, 2026
- EUDAMED 41506995-d688-4cfd-bd32-fa23db3052f5 61 fields · synced May 18, 2026
- EUDAMED 0d2d0839-0424-4114-afbe-484f8042132c 61 fields · synced May 19, 2026
- EUDAMED fcaeaf85-75f9-4cfb-8400-7ede0451deba 61 fields · synced May 19, 2026
- EUDAMED a06b622e-ab34-47d4-8514-19a0c3dff464 61 fields · synced May 19, 2026