Ankle Brace
EUDAMEDClass I (EU MDR)
Identity
- Device Name
- Ankle Brace EUDAMED
- Model / Reference
- AN001,AN002,AN003,AN004,AN005,AN006,AN007,AN008,AN009,AN010,AN011,AN012,AN013,AFO001,AFO002 EUDAMEDAFO002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976200101127 EUDAMED
- Basic UDI-DI
- 697620010AB001ZP EUDAMED
- EMDN Code
- Y090699 DEVICES FOR BODY PROTECTION - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Ankle Brace, a Class I medical device from XIAMEN ORTOCARE SPORTS HEALTH CO., LTD., is designed to provide support and stability for patients with ankle injuries or sprains. This device features a sturdy frame, adjustable straps, and a comfortable grip. The Ankle Brace has undergone rigorous testing and has been approved for use in various markets. For detailed information on the device, please refer to its technical specifications.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
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 d809b1fe-4beb-4c99-907e-6e4881c5d571 61 fields · synced Oct 6, 2026