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Lower Limb Brace(Walker Boot)
EUDAMEDClass I (EU MDR)
Ref Walker Boot-XXXLModel XXS,XS,S,M,L,XL,XXL,XXXLRef Walker Boot-MRef Walker Boot-XSRef Walker Boot-LRef Walker Boot-XXLRef Walker Boot-XL
Identity
- Device Name
- Lower Limb Brace(Walker Boot) EUDAMED
- Model / Reference
- XXS,XS,S,M,L,XL,XXL,XXXL EUDAMEDWalker Boot-XXXL EUDAMEDWalker Boot-M EUDAMEDWalker Boot-XS EUDAMEDWalker Boot-L EUDAMEDWalker Boot-XXL EUDAMEDWalker Boot-XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975813112636 EUDAMED06975813112599 EUDAMED06975813112575 EUDAMED06975813112605 EUDAMED06975813112629 EUDAMED06975813112612 EUDAMED
- Basic UDI-DI
- 697581311WB02LA 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(Walker Boot) 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 | 697581311WB02LA | 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 (6)
- EUDAMED 9001b8e9-fc33-40ac-994f-1f59a21cddb0 61 fields · synced Jul 22, 2026
- EUDAMED 0f89c2a1-2586-442f-829f-3beb0d30d184 61 fields · synced May 17, 2026
- EUDAMED 08f34fc6-6c38-434f-bc29-1c1124eb89cc 61 fields · synced May 17, 2026
- EUDAMED f8c64989-f45b-4ae7-91c2-51fa4319779c 61 fields · synced May 17, 2026
- EUDAMED d03e5908-4625-4ba6-a830-d8933e7d5614 61 fields · synced May 18, 2026
- EUDAMED 8fd36328-ab99-402a-b422-e00f31943285 61 fields · synced May 18, 2026