Identity
- Trade Name
- AQUASPIKE-Y EUDAMED
- Device Name
- Extracorporeal therapies accessories EUDAMED
- Model / Reference
- 1402104406 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053879801225 EUDAMED
- Basic UDI-DI
- 805387980HA0059P EUDAMED
- EMDN Code
- F020180 ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - ACCESSORIES 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
Aquaspike-Y 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 | 805387980HA0059P | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GVS S.p.A.
- EUDAMED SRN
- IT-MF-000028147
Sources (1)
- EUDAMED 30e22110-2266-40d1-95e0-d36d14ebdcec 61 fields · synced Jun 20, 2026