Identity
- Trade Name
- Hero Gauntlet EUDAMED
- Device Name
- Hero Gauntlet EUDAMED
- Model / Reference
- 5001023 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060639240524 EUDAMED
- Basic UDI-DI
- 506063924HEROGAUNTLETZ9 EUDAMED
- Direct Marketing DI
- 05060639240524 EUDAMED
- EMDN Code
- P090499 HAND PROSTHESES - OTHER 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 Gauntlet 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 | 506063924HEROGAUNTLETZ9 | 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 300ceeaa-7b15-4a26-a577-d213dc9dda93 61 fields · synced Jul 8, 2026