InhwRior
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- InhwRior EUDAMEDFDA UDI
- Generic Name
- Nail fungus treatment kit, medicated FDA UDI
- Device Name
- Bunion Corrector EUDAMEDIngrown Toenail Corrector EUDAMEDMaintains alignment after congenital toe deformity corrections FDA UDI
- Model / Reference
- FZJZQ-1 EUDAMED19-21mm EUDAMEDYC-JGYJZQ-003 EUDAMEDYC-FZJZQ-002 FDA UDI
- Description
- Maintains alignment after congenital toe deformity corrections FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06978785665025 EUDAMEDFDA UDI06978785665162 EUDAMED
- Basic UDI-DI
- 6978785662502MH EUDAMED6978785662516MU EUDAMED
- FDA Product Code
- KNP 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 | 6978785662502MH | 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 (3)
- EUDAMED 82c6d5cb-bae9-44e3-8120-531559a365b3 61 fields · synced Jul 26, 2026
- EUDAMED cbafa0d5-4efa-48e6-b814-186598e13df9 61 fields · synced May 19, 2026
- FDA UDI b9cc3eb7-bfaf-4d55-9a33-b863ce9e9db5 33 fields · synced May 30, 2026