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Wrist Brace
EUDAMEDClass I (EU MDR)
Ref WR022Model WR001,WR002,WR003,WR004,WR005,WR006,WR007,WR008,WR009,WR010,WR011,WR012,WR015,WR016,WR017,WR018,WR019,WR020,WR021,WR022,WR023,WR024,WR025
Identity
- Device Name
- Wrist Brace EUDAMED
- Model / Reference
- WR001,WR002,WR003,WR004,WR005,WR006,WR007,WR008,WR009,WR010,WR011,WR012,WR015,WR016,WR017,WR018,WR019,WR020,WR021,WR022,WR023,WR024,WR025 EUDAMEDWR022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976200101905 EUDAMED
- Basic UDI-DI
- 697620010wristbrace001VJ EUDAMED
- EMDN Code
- Y090612 ARM AND ELBOW PROTECTIONS 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
Wrist 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 | 697620010wristbrace001VJ | 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 a5880a98-69a8-4949-a651-acd0747e95d9 61 fields · synced Oct 6, 2026