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Lower Limb Brace
EUDAMEDClass I (EU MDR)
Ref F304Model F101-1 F101-2 F101-3 F101-4 F102-1 F102-2 F102-3 F102-4 F102-5 F102-6 F102-7 F102-8 F103-1 F103-2 F103-3 F103-4 F103-5 F103-6 F104-1 F104-2 F104-3 F104-4 F104-5 F105-1 F105-2 F105-3 F105-4 F201-1 F201-2 F201-3 F201-4 F201-5 F201-6 F201-7 etc
Identity
- Device Name
- Lower Limb Brace EUDAMED
- Model / Reference
- F101-1 F101-2 F101-3 F101-4 F102-1 F102-2 F102-3 F102-4 F102-5 F102-6 F102-7 F102-8 F103-1 F103-2 F103-3 F103-4 F103-5 F103-6 F104-1 F104-2 F104-3 F104-4 F104-5 F105-1 F105-2 F105-3 F105-4 F201-1 F201-2 F201-3 F201-4 F201-5 F201-6 F201-7 etc EUDAMEDF304 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974286370291 EUDAMED
- Basic UDI-DI
- 697428637LLB01MP 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 by Anping Yikang Medical Instrument Co., Ltd — 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 | 697428637LLB01MP | Class I | Active |
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Manufacturer
- Manufacturer
- Anping Yikang Medical Instrument Co., Ltd
- EUDAMED SRN
- CN-MF-000045899
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 7cd5ce4d-7168-44c4-a59f-b1f7c4060997 61 fields · synced Jun 19, 2026