Identity
- Trade Name
- VOLUFIX PLUS EUDAMEDVOLUFIX PLUS WITH NEEDLE EUDAMED
- Device Name
- Infusion Set with / without Needle EUDAMED
- Model / Reference
- GS-3082P EUDAMEDGS-3082PN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902120308221 EUDAMED08902120308214 EUDAMED
- Basic UDI-DI
- 8902120C014RX EUDAMED
- EMDN Code
- A03010103 INFUSION CONTROLLERS WITH FLOW REGULATOR 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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Volufix Plus 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 | 8902120C014RX | 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 2b43b330-3816-41d5-a7af-4e88202c3bea 61 fields · synced Jul 11, 2026
- EUDAMED 5fd4cab2-0186-44df-8863-261fc7fc4f26 61 fields · synced May 19, 2026