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Shoulder&Arm Brace
EUDAMEDClass I (EU MDR)
Ref SH004Model AR001,AR002,AR003,AR004,AR005,AR006,AR007,CL001,CL002,CL003,CL003,SH001,SH002,SH003,SH004,SH005
Identity
- Device Name
- Shoulder&Arm Brace EUDAMED
- Model / Reference
- AR001,AR002,AR003,AR004,AR005,AR006,AR007,CL001,CL002,CL003,CL003,SH001,SH002,SH003,SH004,SH005 EUDAMEDSH004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976200101271 EUDAMED
- Basic UDI-DI
- 697620010SAB0016A 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
Shoulder&Arm 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 | 697620010SAB0016A | 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 fdb103b3-e65d-4ab9-9cf2-ddbbebc76311 61 fields · synced Oct 7, 2026