Identity
- Trade Name
- CYBOW 10 FDA UDI
- Generic Name
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- The one device that has DI number included 100 strips FDA UDI
- Model / Reference
- 0004 FDA UDI
- Description
- The one device that has DI number included 100 strips FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806141302070 FDA UDI
- FDA Product Code
- JIO FDA UDILJX FDA UDIJJB FDA UDIJIL FDA UDIJIN FDA UDIJMT FDA UDICEN FDA UDIJIR FDA UDICDM FDA UDIJRE FDA UDI
- GMDN Term
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.6550 FDA UDI864.7675 FDA UDI862.1115 FDA UDI862.1340 FDA UDI862.1435 FDA UDI862.1510 FDA UDI862.1550 FDA UDI862.1645 FDA UDI862.1785 FDA UDI862.2800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Cybow 10 by Dfi Co., Ltd — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dfi Co., Ltd
Sources (2)
- FDA UDI 23c28226-47bf-42ae-a273-403e852c9fdd 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026