Identity
- Trade Name
- SOFTPAC 130 EUDAMED
- Device Name
- Connectors EUDAMED
- Model / Reference
- 1401304014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053879801423 EUDAMED
- Basic UDI-DI
- 805387980HC0039Z EUDAMED
- EMDN Code
- F9080 DIALYSIS DEVICES - OTHER ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
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
Softpac 130 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 | 805387980HC0039Z | Class I | Active |
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Manufacturer
- Manufacturer
- GVS S.p.A.
- EUDAMED SRN
- IT-MF-000028147
Sources (1)
- EUDAMED 5f815230-306a-426a-b171-011ead93e85e 61 fields · synced Jul 27, 2026