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Ankle external brace
EUDAMEDClass I (EU MDR)
Ref AS011Model AS001 AS002 AS003 AS004 AS005 AS006 AS007 AS008 AS009 AS010 AS011 AS012 AS013 AS015 AS016 AS017 AS018 AS019 AS020
Identity
- Device Name
- Ankle external brace EUDAMED
- Model / Reference
- AS001 AS002 AS003 AS004 AS005 AS006 AS007 AS008 AS009 AS010 AS011 AS012 AS013 AS015 AS016 AS017 AS018 AS019 AS020 EUDAMEDAS011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975816761992 EUDAMED
- Basic UDI-DI
- 697581676AEB001GY 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
Yes
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
Ankle external brace by Xiamen Huakang Orthopedic Co., Ltd — 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 | 697581676AEB001GY | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Huakang Orthopedic Co., Ltd
- EUDAMED SRN
- CN-MF-000002290
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 1e10d0d9-f6c0-424b-8574-8016d4620151 61 fields · synced Oct 6, 2026