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Night Splint with Anti-Rotation Foot Support
EUDAMEDClass I (EU MDR)
Ref 1002-1Model Lower Limb Orthoses
Identity
- Trade Name
- Night Splint with Anti-Rotation Foot Support EUDAMED
- Model / Reference
- Lower Limb Orthoses EUDAMED1002-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867217197 EUDAMED
- Basic UDI-DI
- 697886721LO000R5 EUDAMED
- Direct Marketing DI
- 06978867217197 EUDAMED
- EMDN Code
- Y0699 EXTERNAL PROSTHESES AND ORTHOSES - 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
Night Splint with Anti-Rotation Foot Support by Medi Global Assistive Device 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 | 697886721LO000R5 | Class I | Active |
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Manufacturer
- Manufacturer
- Medi Global Assistive Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000034804
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED 5c50d8b6-f35c-4430-b49c-186bc13395cf 61 fields · synced Jul 9, 2026