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Ankle external brace
EUDAMEDClass I (EU MDR)
Ref AS001 AS002 AS003 AS004 AS005 AS006 AS007 AS008 AS009 AS010 AS011 AS012 AS013 AS015 AS016 AS017 AS018 AS019Model 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 EUDAMEDAS001 AS002 AS003 AS004 AS005 AS006 AS007 AS008 AS009 AS010 AS011 AS012 AS013 AS015 AS016 AS017 AS018 AS019 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975816760025 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 — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 712c43e7-6015-4693-ab9c-4d5973993d82 61 fields · synced Oct 6, 2026