Identity
- Trade Name
- NIK3188 EUDAMED
- Device Name
- Waste bags EUDAMED
- Model / Reference
- 1531885406 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053879801287 EUDAMED
- Basic UDI-DI
- 805387980WB008F9 EUDAMED
- EMDN Code
- F90040101 HAEMODIALYSATE COLLECTION BAGS 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
Nik3188 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 | 805387980WB008F9 | Class I | Active |
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Manufacturer
- Manufacturer
- GVS S.p.A.
- EUDAMED SRN
- IT-MF-000028147
Sources (1)
- EUDAMED e5a5e8d2-8584-4839-b91c-577fbd400ac5 61 fields · synced Jul 21, 2026