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Upper Limb Brace（Elbow Brace）
EUDAMEDClass I (EU MDR)
Ref Elbow Brace-MModel XXS,XS,S,M,L,XL,XXL,XXXLRef Elbow Brace-XXXLRef Elbow Brace-LRef Elbow Brace-XXL
Identity
- Device Name
- Upper Limb Brace（Elbow Brace） EUDAMED
- Model / Reference
- XXS,XS,S,M,L,XL,XXL,XXXL EUDAMEDElbow Brace-M EUDAMEDElbow Brace-XXXL EUDAMEDElbow Brace-L EUDAMEDElbow Brace-XXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975813110519 EUDAMED06975813110557 EUDAMED06975813110526 EUDAMED06975813110540 EUDAMED
- Basic UDI-DI
- 697581311EB01GA EUDAMED
- EMDN Code
- Y060615 ELBOW ORTHOSES 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
Upper Limb Brace（Elbow Brace） by Anping Huakang Medical Products Factory — Class I — 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 | 697581311EB01GA | Class I | Active |
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Manufacturer
- Manufacturer
- AnPing HuaKang Medical Products Factory
- EUDAMED SRN
- CN-MF-000036122
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED ce196d8f-514f-47fc-a0d6-c0a4e032d677 61 fields · synced Jul 26, 2026
- EUDAMED ebd3f2f6-bd18-445d-a6f3-a7f57c1484a8 61 fields · synced May 17, 2026
- EUDAMED 4ba328e2-b50f-450f-8e71-b1f681c32e37 61 fields · synced May 17, 2026
- EUDAMED 9ad86de3-21ee-4725-b95d-53103eb4b2f0 61 fields · synced May 18, 2026