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Upper Limb Brace(Wrist Brace)
EUDAMEDClass I (EU MDR)
Ref Wrist Brace-XXXLModel XXS,XS,S,M,L,XL,XXL,XXXLRef Wrist Brace-XLRef Wrist Brace-XXSRef Wrist Brace-XXLRef Wrist Brace-XS
Identity
- Device Name
- Upper Limb Brace(Wrist Brace) EUDAMED
- Model / Reference
- XXS,XS,S,M,L,XL,XXL,XXXL EUDAMEDWrist Brace-XXXL EUDAMEDWrist Brace-XL EUDAMEDWrist Brace-XXS EUDAMEDWrist Brace-XXL EUDAMEDWrist Brace-XS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975813110397 EUDAMED06975813110373 EUDAMED06975813110328 EUDAMED06975813110380 EUDAMED06975813110335 EUDAMED
- Basic UDI-DI
- 697581311WB01L8 EUDAMED
- EMDN Code
- Y060609 WRIST (FOREARM) 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(Wrist 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 | 697581311WB01L8 | 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 89d2ab0e-213e-4b1c-991b-d3ac30e07308 61 fields · synced Aug 1, 2026
- EUDAMED 0b32e71d-9606-41ea-8807-3253cbf8bebc 61 fields · synced May 17, 2026
- EUDAMED 4d21ef5f-4cd0-471b-9f1d-5d4602c840b7 61 fields · synced May 17, 2026
- EUDAMED a8913ead-f846-4495-989e-ee12f4e0c279 61 fields · synced May 18, 2026
- EUDAMED dbdd926e-d7d8-44ac-89d9-c2542d9d10f9 61 fields · synced May 18, 2026