Identity
- Device Name
- Kids Stabilized Wrist Brace Left EUDAMED
- Model / Reference
- 895KL EUDAMED895K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05063000895002 EUDAMED05063000895019 EUDAMED
- Basic UDI-DI
- 5063000895KKE EUDAMED
- EMDN Code
- Y060609 WRIST (FOREARM) ORTHOSES 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
Kids Stabilized Wrist Brace Left 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 | 5063000895KKE | 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 (2)
- EUDAMED fb369a7b-550a-4477-a8bc-c5f941cce511 61 fields · synced Jul 22, 2026
- EUDAMED c4375626-0405-4f3e-aec9-9df750ebfe75 61 fields · synced May 19, 2026