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Night Splint
EUDAMEDClass I (EU MDR)
Ref NS004Model NS001,NS002,NS003,NS004,NS005,NS006,AFO001,AFO002
Identity
- Device Name
- Night Splint EUDAMED
- Model / Reference
- NS001,NS002,NS003,NS004,NS005,NS006,AFO001,AFO002 EUDAMEDNS004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976200100939 EUDAMED
- Basic UDI-DI
- 697620010NS0019Y EUDAMED
- EMDN Code
- Y090699 DEVICES FOR BODY PROTECTION - 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
Night Splint by Xiamen Ortocare Sports Health Co., 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 | 697620010NS0019Y | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Ortocare Sports Health Co., Ltd.
- EUDAMED SRN
- CN-MF-000034229
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 635dce4b-e7bc-436e-aa64-b63f995870e7 61 fields · synced Jun 17, 2026