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Ankle Brace
EUDAMEDClass I (EU MDR)
Ref -Model AN001,AN002,AN003,AN004,AN005,AN006,AN007,AN008,AN009,AN010,AN011,AN012,AN013,AFO001,AFO002
Identity
- Device Name
- Ankle Brace EUDAMED
- Model / Reference
- AN001,AN002,AN003,AN004,AN005,AN006,AN007,AN008,AN009,AN010,AN011,AN012,AN013,AFO001,AFO002 EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976200100045 EUDAMED
- Basic UDI-DI
- 697620010AB001ZP EUDAMED
- EMDN Code
- Y090618 LEG AND KNEE PROTECTIONS (INCLUDING SOCKS FOR AMPUTATED LEGS) 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
Ankle Brace by Xiamen Ortocare Sports Health Co., Ltd. — Class I — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697620010AB001ZP | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Ortocare Sports Health Co., Ltd.
- EUDAMED SRN
- CN-MF-000034229
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED ad685a31-53b4-4eb0-9c0a-6ddd51b4baab 61 fields · synced Oct 6, 2026