Identity
- Device Name
- Hand Rehabilitation Fist Shaped EUDAMED
- Model / Reference
- 350 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05063000350105 EUDAMED
- Basic UDI-DI
- 5063000350Z6 EUDAMED
- EMDN Code
- Y241899 ARM, HAND, FINGER FUNCTION AID AND/OR SUBSTITUTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Hand Rehabilitation Fist Shaped by Neo G Limited — 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 | 5063000350Z6 | Class I | Active |
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Manufacturer
- Manufacturer
- Neo G Limited
- EUDAMED SRN
- GB-MF-000004603
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (1)
- EUDAMED e46a3e86-9055-4da6-8137-5c539e16c26e 61 fields · synced Jun 19, 2026