Identity
- Trade Name
- HI-FLO IV Extension Set EUDAMED
- Device Name
- Infusion Devices Class IIa EUDAMED
- Model / Reference
- GSS003A02S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053879800235 EUDAMED
- Basic UDI-DI
- 805387980SETINF2A0000003T EUDAMED
- EMDN Code
- A03020101 LOW PRESSURE EXTENSION LINES 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
HI-FLO IV Extension Set by GVS S.p.A. — 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 | 805387980SETINF2A0000003T | Class IIa | Active |
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Manufacturer
- Manufacturer
- GVS S.p.A.
- EUDAMED SRN
- IT-MF-000028147
Sources (1)
- EUDAMED bcdbcedf-07b9-428e-8e51-27f875909e97 61 fields · synced Jul 19, 2026