Identity
- Trade Name
- Hero Lite EUDAMED
- Device Name
- Hero Lite EUDAMED
- Model / Reference
- 5001055 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060639240425 EUDAMED
- Basic UDI-DI
- 0506063924HeroLite2E EUDAMED
- Direct Marketing DI
- 05060639240425 EUDAMED
- EMDN Code
- P090299,P090399,P090499,Z12062705 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Hero Lite by Open Bionics Ltd. — 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 | 0506063924HeroLite2E | Class I | Active |
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Manufacturer
- Manufacturer
- Open Bionics Ltd.
- EUDAMED SRN
- GB-MF-000032650
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (1)
- EUDAMED 64eeebdc-3136-49b9-8344-41118d36bc3c 61 fields · synced Oct 6, 2026