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Lower Limb Brace(Bunion Toe Corrector)
EUDAMEDClass I (EU MDR)
Ref Bunion Toe Corrector-XXXLModel XXS,XS,S,M,L,XL,XXL,XXXLRef Bunion Toe Corrector-XLRef Bunion Toe Corrector-SRef Bunion Toe Corrector-MRef Bunion Toe Corrector-XXLRef Bunion Toe Corrector-XXSRef Bunion Toe Corrector-L
Identity
- Device Name
- Lower Limb Brace(Bunion Toe Corrector) EUDAMED
- Model / Reference
- XXS,XS,S,M,L,XL,XXL,XXXL EUDAMEDBunion Toe Corrector-XXXL EUDAMEDBunion Toe Corrector-XL EUDAMEDBunion Toe Corrector-S EUDAMEDBunion Toe Corrector-M EUDAMEDBunion Toe Corrector-XXL EUDAMEDBunion Toe Corrector-XXS EUDAMEDBunion Toe Corrector-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975813112872 EUDAMED06975813112858 EUDAMED06975813112827 EUDAMED06975813112834 EUDAMED06975813112865 EUDAMED06975813112803 EUDAMED06975813112841 EUDAMED
- Basic UDI-DI
- 697581311BTC01G9 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
Category: Orthotic insole, prefabricated, non-antimicrobial
Lower Limb Brace(Bunion Toe Corrector) by Anping Huakang Medical Products Factory — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthotic insole, prefabricated, non-antimicrobial.
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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 | 697581311BTC01G9 | 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 (7)
- EUDAMED e1e4ed2a-1e51-4e40-8537-6508d687b787 61 fields · synced Jul 27, 2026
- EUDAMED 7be30e67-8ca0-442a-9042-fd669a9f1e48 61 fields · synced May 17, 2026
- EUDAMED f2fc2ce3-fcd6-4a37-9ab8-1b41b2d971f5 61 fields · synced May 19, 2026
- EUDAMED aa12090f-75e5-4d56-b26f-aab6d0ff12ee 61 fields · synced May 19, 2026
- EUDAMED be33c4d2-2c4e-41a0-b6da-7a3b1f8346de 61 fields · synced May 19, 2026
- EUDAMED 1078b621-813e-4b14-a57a-c7d5f07dd6fc 61 fields · synced May 19, 2026
- EUDAMED a03567c9-755b-4ccd-8143-494aa9ca3be6 61 fields · synced May 19, 2026