Identity
- Trade Name
- HB500 EUDAMED
- Device Name
- HB500 EUDAMEDFLASH EUDAMED
- Model / Reference
- HB500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053904843534 EUDAMED
- Basic UDI-DI
- 805390484350DT EUDAMED
- Direct Marketing DI
- 08053904843534 EUDAMED
- EMDN Code
- Y121809 MANUALLY PROPELLED TRICYCLES 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
Hb500 by OFF CARR Srl — 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 | 805390484350DT | Class I | Active |
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Manufacturer
- Manufacturer
- OFF CARR Srl
- EUDAMED SRN
- IT-MF-000024334
Sources (2)
- EUDAMED 341a29c6-b599-4d22-b2c7-d9327852b324 61 fields · synced Jun 19, 2026
- EUDAMED 28209b30-1904-478a-a8f3-f2ce42c2def2 61 fields · synced Jun 19, 2026