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Lower Limb Brace（3-Panel Knee Brace）
EUDAMEDClass I (EU MDR)
Ref 3-Panel Knee Brace-12"Model 12''、14 ''、16''、 20''、 22''、 24''
Identity
- Device Name
- Lower Limb Brace（3-Panel Knee Brace） EUDAMED
- Model / Reference
- 12''、14 ''、16''、 20''、 22''、 24'' EUDAMED3-Panel Knee Brace-12" EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975813113015 EUDAMED
- Basic UDI-DI
- 6975813113PKB01BQ EUDAMED
- EMDN Code
- Y061209 KNEE 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
Lower Limb Brace（3-Panel Knee 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 | 6975813113PKB01BQ | 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 (1)
- EUDAMED 55d3aa57-92b7-438e-9bac-d1ada5976009 61 fields · synced Jun 19, 2026