Qtest K
FDA UDIEUDAMEDClass I (US FDA UDI)
by Dfi Co., Ltd
Identity
- Trade Name
- CYBOW K EUDAMEDQTEST K FDA UDI
- Generic Name
- Urine ketone IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- CYBOW Series EUDAMED100 strips/ 1 bottle FDA UDI
- Model / Reference
- 0124 EUDAMEDFDA UDICYBOW Series EUDAMED
- Description
- 100 strips/ 1 bottle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806141304630 EUDAMED08806141301592 FDA UDI
- Basic UDI-DI
- 88061413US31D0JC EUDAMED
- FDA Product Code
- JIN FDA UDI
- EMDN Code
- W01010999 MULTIPLE PARAMETERS URINE TESTING - OTHER EUDAMED
- GMDN Term
- Urine ketone IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1435 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
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
Yes
Manufacturing Date
Yes
Category: Urine ketone IVD, kit, rapid colorimetric, clinical
Qtest K by Dfi Co., Ltd — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dfi Co., Ltd
Sources (2)
- FDA UDI 9fcc7e85-df6e-4ea9-a0a3-1aecd0971b2a 34 fields · synced Aug 1, 2026
- EUDAMED 1642ea44-8806-4024-bbc0-35693a87c66f 61 fields · synced Jul 28, 2026