Identity
- Trade Name
- FLEXO CATH EUDAMED
- Device Name
- Thoracic Drainage Catheter EUDAMED
- Model / Reference
- GS-5034 EUDAMEDGS-5034A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902120503473 EUDAMED08902120503534 EUDAMED08902120503466 EUDAMED08902120503565 EUDAMED08902120503510 EUDAMED08902120503411 EUDAMED08902120503435 EUDAMED08902120503404 EUDAMED
- Basic UDI-DI
- 8902120G003SN EUDAMED
- EMDN Code
- A0601010401 THORACIC DRAINAGES (STRAIGHT AND ANGLED) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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 International (Unit II) — 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 | 8902120G003SN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Romsons International (Unit II)
- EUDAMED SRN
- IN-MF-000024594
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (8)
- EUDAMED 3fc6b8ae-7b5a-4d4c-ac21-314536b06fdf 61 fields · synced Aug 1, 2026
- EUDAMED a1f0ee7e-e005-4c81-8fec-7dd3af555bdb 61 fields · synced May 16, 2026
- EUDAMED 984f7385-6cf3-4bae-afcc-6ffaf48ec3c9 61 fields · synced May 17, 2026
- EUDAMED 1fa4e9ef-6341-4057-a5d4-70338777f503 61 fields · synced May 19, 2026
- EUDAMED 2abb9190-e2f2-486a-bc51-85c658dc196b 61 fields · synced May 19, 2026
- EUDAMED f11ccd8d-dc81-49a7-a392-8c187e920ceb 61 fields · synced May 19, 2026
- EUDAMED 30436fc3-9756-4e56-ad3a-7ccae9dbac49 61 fields · synced May 19, 2026
- EUDAMED 18a81d22-606e-4966-b65b-eaa7dfbabb45 61 fields · synced May 19, 2026