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Lower Limb Brace(Plantar Fasciitis Night Splint)
EUDAMEDClass I (EU MDR)
Ref Plantar Fasciitis Night Splint-MModel XXS,XS,S,M,L,XL,XXL,XXXL
Identity
- Device Name
- Lower Limb Brace(Plantar Fasciitis Night Splint) EUDAMED
- Model / Reference
- XXS,XS,S,M,L,XL,XXL,XXXL EUDAMEDPlantar Fasciitis Night Splint-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975813112674 EUDAMED
- Basic UDI-DI
- 697581311PFNS01NY EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT 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
Category: Ankle/foot orthosis
Lower Limb Brace(Plantar Fasciitis Night Splint) by Anping Huakang Medical Products Factory — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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 | 697581311PFNS01NY | Class I | Active |
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Manufacturer
- Manufacturer
- AnPing HuaKang Medical Products Factory
- EUDAMED SRN
- CN-MF-000036122
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED e8734d59-44aa-444a-9925-d97c1cff1b06 61 fields · synced Oct 6, 2026