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Romsons 14g
EUDAMEDClass IIa (EU MDR)
Ref GS-3158Model INTRA VENOUS CANNULARef GS-3166
Identity
- Trade Name
- ROMSONS 14G EUDAMED
- Device Name
- INTRA VENOUS CANNULA EUDAMED
- Model / Reference
- INTRA VENOUS CANNULA EUDAMEDGS-3158 EUDAMEDGS-3166 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902120315816 EUDAMED08902120316615 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 14g 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 1581d9ac-5d7f-429f-9eb6-518c93e373bf 61 fields · synced Jul 12, 2026
- EUDAMED f05ea869-2631-4820-b908-73e6ec101b54 61 fields · synced May 18, 2026