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Upper Limb Brace(Hand Brace)
EUDAMEDClass I (EU MDR)
Ref Hand Brace-XXLModel XXS,XS,S,M,L,XL,XXL,XXXLRef Hand Brace-XS
Identity
- Device Name
- Upper Limb Brace(Hand Brace) EUDAMED
- Model / Reference
- XXS,XS,S,M,L,XL,XXL,XXXL EUDAMEDHand Brace-XXL EUDAMEDHand Brace-XS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975813110700 EUDAMED06975813110656 EUDAMED
- Basic UDI-DI
- 697581311HB01GX EUDAMED
- EMDN Code
- Y060606 HAND 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(Hand 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 | 697581311HB01GX | 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 (2)
- EUDAMED 6ad8677a-22f8-490a-9f81-8bc599bd5a35 61 fields · synced Jul 31, 2026
- EUDAMED 68ede5c8-0d52-4949-b515-d3fc645c981c 61 fields · synced May 18, 2026