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Upper Limb Brace(Shoulder Brace)
EUDAMEDClass I (EU MDR)
Ref Shoulder Brace-MModel XXS,XS,S,M,L,XL,XXL,XXXLRef Shoulder Brace-XXLRef Shoulder Brace-XSRef Shoulder Brace-XLRef Shoulder Brace-XXXL
Identity
- Device Name
- Upper Limb Brace(Shoulder Brace) EUDAMED
- Model / Reference
- XXS,XS,S,M,L,XL,XXL,XXXL EUDAMEDShoulder Brace-M EUDAMEDShoulder Brace-XXL EUDAMEDShoulder Brace-XS EUDAMEDShoulder Brace-XL EUDAMEDShoulder Brace-XXXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975813110113 EUDAMED06975813110144 EUDAMED06975813110090 EUDAMED06975813110137 EUDAMED06975813110151 EUDAMED
- Basic UDI-DI
- 697581311SB01KC EUDAMED
- EMDN Code
- Y060621 SHOULDER 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 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 | 697581311SB01KC | 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 (5)
- EUDAMED 00321805-649d-4eff-a7a8-9ab386a69b72 61 fields · synced Jul 23, 2026
- EUDAMED dc2546ce-7ced-44cf-a668-e27810c99973 61 fields · synced May 17, 2026
- EUDAMED f9dfb639-5585-4221-85ca-7c225637431d 61 fields · synced May 18, 2026
- EUDAMED eefe1dcf-d089-478c-9bcd-2b2ef85cf62c 61 fields · synced May 18, 2026
- EUDAMED 3cbefc4a-6507-4c7c-a9bf-12abb98b406b 61 fields · synced May 18, 2026