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Bunion Hallux Valgus Night Splint Left
EUDAMEDClass I (EU MDR)
Ref 511Model 511L
Identity
- Device Name
- Bunion Hallux Valgus Night Splint Left EUDAMED
- Model / Reference
- 511L EUDAMED511 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05063000511018 EUDAMED
- Basic UDI-DI
- 5063000511Z6 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) 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
Bunion Hallux Valgus Night Splint 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 | 5063000511Z6 | 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 4b141427-bee0-4829-8d38-6cfc881787e3 61 fields · synced Jun 18, 2026