Identity
- Trade Name
- InhwRior EUDAMEDFDA UDI
- Generic Name
- Nail fungus treatment kit, medicated FDA UDI
- Device Name
- Ingrown Toenail Corrector EUDAMEDThis device is designed for application to pincer nails (curled nails) or deformed toenails to alleviate pain and improve nail morphology through biomechanical remodeling. FDA UDI
- Model / Reference
- 21-23mm EUDAMEDYC-JGYJZQ-003 EUDAMEDFDA UDI
- Description
- This device is designed for application to pincer nails (curled nails) or deformed toenails to alleviate pain and improve nail morphology through biomechanical remodeling. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06978785665032 EUDAMEDFDA UDI
- Basic UDI-DI
- 6978785662503MK EUDAMED
- FDA Product Code
- ITW FDA UDI
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
- GMDN Term
- Nail fungus treatment kit, medicated FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3475 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Orthotic insole, prefabricated, non-antimicrobial
InhwRior by Shenzhen Yuechuan Trade Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6978785662503MK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Yuechuan trade Co., Ltd.
- EUDAMED SRN
- CN-MF-000048151
- Authorised Representative
- WISELINK MEDICAL, S.L.U. ES-AR-000052118
Sources (2)
- EUDAMED d3de0e53-2315-4a14-99ae-518d989e256f 61 fields · synced Aug 4, 2026
- FDA UDI f13ebd36-5deb-4aaf-9465-6394627afb37 33 fields · synced May 30, 2026