Identity
- Trade Name
- FLEXO CATH EUDAMED
- Device Name
- THORACIC DRAINAGE CATHETER (CHEST DRAINAGE CATHETER) EUDAMED
- Model / Reference
- GS-5034 EUDAMEDGS-5034 KAD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265503425 EUDAMED08907265503449 EUDAMED08907265000108 EUDAMED08907265010572 EUDAMED08907265010558 EUDAMED08907265010527 EUDAMED08907265010541 EUDAMED08907265010589 EUDAMED08907265503432 EUDAMED08907265010534 EUDAMED08907265012989 EUDAMED08907265503401 EUDAMED08907265012972 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 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 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 (13)
- EUDAMED 8e46736e-5d1b-4b5a-9fb4-d3e43d3b33df 61 fields · synced Jul 25, 2026
- EUDAMED 6388b222-f5cc-40ec-b863-6d99c73c6437 61 fields · synced May 16, 2026
- EUDAMED fb967d05-d8a8-4011-a8ca-9b56d719b01a 61 fields · synced May 17, 2026
- EUDAMED 93cd96e4-a5c2-4dcd-b783-a5c9b5328a57 61 fields · synced May 17, 2026
- EUDAMED 5c5c8c29-7c39-4e0e-94b6-d9d074ba551c 61 fields · synced May 17, 2026
- EUDAMED b021e916-2fff-472c-8d37-7e51b8f008e9 61 fields · synced May 18, 2026
- EUDAMED ab15b622-0f2e-436a-ae9a-e7b802dd8c81 61 fields · synced May 18, 2026
- EUDAMED 737540aa-2001-4ce6-85c0-e572fa5ba730 61 fields · synced May 19, 2026
- EUDAMED 12af4a94-5d68-4e58-8a97-361e3107306d 61 fields · synced May 19, 2026
- EUDAMED 635a0171-67a3-47a4-95ac-ebee4ffe8fbf 61 fields · synced May 19, 2026
- EUDAMED 30b38fd2-b234-42f7-95db-c59052d7f01c 61 fields · synced May 19, 2026
- EUDAMED 153a6d1d-9474-4290-a477-0a22cf64dd17 61 fields · synced May 19, 2026
- EUDAMED 93e85079-35a2-4581-9566-cf98dec557a2 61 fields · synced May 19, 2026