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Lower Limb Brace
EUDAMEDClass I (EU MDR)
Ref G217-1Model 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 EUDAMEDG217-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974286371595 EUDAMED
- Basic UDI-DI
- 697428637LLB01MP EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT 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
Category: Ankle/foot orthosis
Lower Limb Brace by Anping Yikang Medical Instrument Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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 52b89eac-1fdc-41ad-9bf7-599013e0332b 61 fields · synced Jun 19, 2026