← Back to catalogue
Lower Limb Brace
EUDAMEDClass I (EU MDR)
Ref G216-1Model 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 EUDAMEDG216-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974286371588 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
Similar devices
Also classified as Ankle/foot orthosis.
- Strp Only, Long, SA Wide Fl 12.5 E Stop — Becker Orthopedic Appliance Company · Class I
- Strp, SFL, 8.25in C Stop , AJT, SA, B — Becker Orthopedic Appliance Company · Class I
- Strp, Spl, WF Cal Pl, AJT, SA B, Free Mot LM/RL — Becker Orthopedic Appliance Company · Class I
- ALIMED ANKLE BRACE ALL AIR TUBE — AliMed, LLC · Class I
- Ankle support with 2 straps - Neoprene - onesize — ΜΙΧΑΛΗΣ ΚΟΥΓΙΟΥΜΤΖΗΣ ΚΑΙ ΣΙΑ Ε.Ε. · Class I
- Rebound® Air Walker LT — Össur Iceland ehf. · Class I
- Strp Blank Insert Only, SA, A/B Size, 3in Free Mot — Becker Orthopedic Appliance Company · Class I
- STABIBOOT 3D — GROUPE SOBER SAS · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
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 451b9dd8-1d4f-4dab-871b-643a311a8695 61 fields · synced Jun 18, 2026