Identity
- Trade Name
- HI-FLO IV Set EUDAMED
- Device Name
- Infusion Devices Class Is EUDAMED
- Model / Reference
- GIS011D01S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053879800877 EUDAMED
- Basic UDI-DI
- 805387980SETINF1S000000CS EUDAMED
- EMDN Code
- A03010103 INFUSION CONTROLLERS WITH FLOW REGULATOR EUDAMED
Classification
- Device Class
- Class I 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 Set by GVS S.p.A. — Class I — 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 | 805387980SETINF1S000000CS | Class I | Active |
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Manufacturer
- Manufacturer
- GVS S.p.A.
- EUDAMED SRN
- IT-MF-000028147
Sources (1)
- EUDAMED c9814183-c4e1-46b5-b544-7d5f2afe438b 61 fields · synced Jul 15, 2026