Identity
- Trade Name
- VEIN-O-LINE EUDAMEDVEIN-O-LINE MARVEL EUDAMED
- Device Name
- Extension Line EUDAMED
- Model / Reference
- GS-3034 EUDAMEDGS-3144 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902120303486 EUDAMED08902120303431 EUDAMED08902120303448 EUDAMED08902120303516 EUDAMED08902120314413 EUDAMED
- Basic UDI-DI
- 8902120C011RR EUDAMED
- EMDN Code
- A03020101 LOW PRESSURE EXTENSION LINES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMEDAustria 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
Vein-O-Line 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 | 8902120C011RR | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Romsons International (Unit II)
- EUDAMED SRN
- IN-MF-000024594
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (5)
- EUDAMED 2e21ea4f-34e8-484c-83b8-a3b3ed9999ba 61 fields · synced Jul 13, 2026
- EUDAMED 8553ca41-1eac-47f9-9cf6-5aca423289a7 61 fields · synced May 17, 2026
- EUDAMED fb68049a-00d2-4cbd-8081-c2eeec671318 61 fields · synced May 19, 2026
- EUDAMED d3a9cfac-7f3a-4e2d-a147-4e8022fb88c2 61 fields · synced May 19, 2026
- EUDAMED cf4713ee-9618-4e24-a1e6-5dfd0133b1a6 61 fields · synced May 19, 2026