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Uniko
EUDAMEDClass I (EU MDR)
Ref 328059MCModel 326040MC, 326080M, 326080MC, 328019MC, 328059M, 328059MC, 326040M, 326060M, 326060MC 328019M, 328040M, 328040MC
Identity
- Trade Name
- UNIKO EUDAMED
- Device Name
- UNIKO EUDAMED
- Model / Reference
- 326040MC, 326080M, 326080MC, 328019MC, 328059M, 328059MC, 326040M, 326060M, 326060MC 328019M, 328040M, 328040MC EUDAMED328059MC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08058302603483 EUDAMED
- Basic UDI-DI
- 805830260UNIKOET EUDAMED
- Direct Marketing DI
- 08058302603483 EUDAMED
- EMDN Code
- V0899 MEDICAL SUPPORT EQUIPMENT - OTHER 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
Uniko by Malvestio Spa — 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 | 805830260UNIKOET | Class I | Active |
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Manufacturer
- Manufacturer
- Malvestio Spa
- EUDAMED SRN
- IT-MF-000013307
Sources (1)
- EUDAMED d66a4b09-70fc-4e38-a72c-ddd730fc83a7 61 fields · synced Jun 18, 2026