Identity
- Trade Name
- NEO CARE EUDAMED
- Device Name
- INTRAVENOUS CANNULA EUDAMED
- Model / Reference
- GS-3211 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265321104 EUDAMED
- Basic UDI-DI
- 8907265C001YH EUDAMED
- EMDN Code
- C0101010102 PERIPHERAL I.V. CATHETERS, W/O SAFETY SYSTEMS, W/O INJECTION VALVES 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Neo Care 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 | 8907265C001YH | 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 (1)
- EUDAMED 1766695a-44c2-464b-956d-c33325a83fd3 61 fields · synced Jul 26, 2026