Upper Limb Brace（Elbow Brace）
by AnPing HuaKang Medical Products Factory FDA registration: China EUDAMED
Ref Elbow Brace-XXLModel XXS,XS,S,M,L,XL,XXL,XXXL EMDN Y060615
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697581311EB01GA | Date9 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Upper Limb Brace（Elbow Brace）
- Model / Reference
- XXS, XS, S, M, L, XL, XXL, XXXL, Elbow Brace-XXL
- Primary DI / UDI-DI
- 06975813110540
- Basic UDI-DI
- 697581311EB01GA
- EMDN Code
- Y060615 Elbow orthoses
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000036122
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- 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
Sources (1)
- EUDAMED 9ad86de3-21ee-4725-b95d-53103eb4b2f0