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Romsons 22g
EUDAMEDClass IIa (EU MDR)
Ref GS-3166Model INTRA VENOUS CANNULARef GS-3158
Identity
- Trade Name
- ROMSONS 22G EUDAMED
- Device Name
- INTRA VENOUS CANNULA EUDAMED
- Model / Reference
- INTRA VENOUS CANNULA EUDAMEDGS-3166 EUDAMEDGS-3158 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902120316653 EUDAMED08902120315854 EUDAMED
- Basic UDI-DI
- 8902120C001RN EUDAMED
- EMDN Code
- C0101010101 PERIPHERAL I.V. CATHETERS, W/O SAFETY SYSTEMS, WITH INJECTION VALVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Romsons 22g 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 | 8902120C001RN | 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 (2)
- EUDAMED 37b45411-847a-4ef1-ab79-9b93e2466cb7 61 fields · synced Jul 28, 2026
- EUDAMED 7baf9125-edcc-4f31-bbc0-b7d6cb2a8fa2 61 fields · synced May 17, 2026