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Hero
EUDAMEDClass I (EU MDR)
Ref 348590BModel 348580SB, 348580B, 348590B, 348590SB
Identity
- Trade Name
- HERO EUDAMED
- Device Name
- TALENT, HERO EUDAMED
- Model / Reference
- 348580SB, 348580B, 348590B, 348590SB EUDAMED348590B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08058302602738 EUDAMED
- Basic UDI-DI
- 805830260JMBJ5 EUDAMED
- Direct Marketing DI
- 08058302602738 EUDAMED
- EMDN Code
- V08060105 ELECTRIC MEDICAL BEDS WITH WEIGHING SYSTEM 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hero 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 | 805830260JMBJ5 | Class I | Active |
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Manufacturer
- Manufacturer
- Malvestio Spa
- EUDAMED SRN
- IT-MF-000013307
Sources (1)
- EUDAMED 135d57be-f1bf-4559-a9f0-ec59ffc9ac75 61 fields · synced Jul 10, 2026