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Upper Limb Brace(Shoulder Orthosis)
EUDAMEDClass I (EU MDR)
Ref Shoulder Orthosis-XXXLModel XXS,XS,S,M,L,XL,XXL,XXXLRef sRef Shoulder Orthosis-XXLRef Shoulder Orthosis-L
Identity
- Device Name
- Upper Limb Brace(Shoulder Orthosis) EUDAMED
- Model / Reference
- XXS,XS,S,M,L,XL,XXL,XXXL EUDAMEDShoulder Orthosis-XXXL EUDAMEDs EUDAMEDShoulder Orthosis-XXL EUDAMEDShoulder Orthosis-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975813110076 EUDAMED06975813110021 EUDAMED06975813110069 EUDAMED06975813110045 EUDAMED
- Basic UDI-DI
- 697581311SO01MD EUDAMED
- EMDN Code
- Y060621 SHOULDER ORTHOSES EUDAMEDY060603 FINGERS 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(Shoulder Orthosis) 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 | 697581311SO01MD | 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 4b8dea5c-8430-4b69-b97a-b5b6ac248437 61 fields · synced Aug 3, 2026
- EUDAMED 27a22c76-43c2-434d-9284-31a9c9e567f2 61 fields · synced May 18, 2026
- EUDAMED ee4b6307-0bc7-4b5e-9412-25ceca4047d8 61 fields · synced May 19, 2026
- EUDAMED 05c54d58-d978-4963-a6fa-9fdd590544f7 61 fields · synced May 19, 2026