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Lower Limb Brace（3-Panel Knee Brace）
EUDAMEDClass I (EU MDR)
Ref 3-Panel Knee Brace-20"Model 12''、14 ''、16''、 20''、 22''、 24''Ref 3-Panel Knee Brace-24"Ref 3-Panel Knee Brace-16"Ref 3-Panel Knee Brace-14"
Identity
- Device Name
- Lower Limb Brace（3-Panel Knee Brace） EUDAMED
- Model / Reference
- 12''、14 ''、16''、 20''、 22''、 24'' EUDAMED3-Panel Knee Brace-20" EUDAMED3-Panel Knee Brace-24" EUDAMED3-Panel Knee Brace-16" EUDAMED3-Panel Knee Brace-14" EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975813113046 EUDAMED06975813113060 EUDAMED06975813113039 EUDAMED06975813113022 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 (4)
- EUDAMED 34a718a3-5476-4583-8c2a-7d81c247b2d9 61 fields · synced Jul 31, 2026
- EUDAMED 57d6c3b2-f465-4cac-ab0a-ba55647fe24e 61 fields · synced May 16, 2026
- EUDAMED 154ab9ae-c358-4f55-8a79-b0a9f25e0a64 61 fields · synced May 18, 2026
- EUDAMED c6c575e0-73f1-43b9-9c3e-49d8064d9e2a 61 fields · synced May 19, 2026