One+Step UTI
FDA UDIEUDAMEDClass I (US FDA UDI)
by Dfi Co., Ltd
Identity
- Trade Name
- DUS 3 EUDAMEDOne+Step UTI FDA UDI
- Generic Name
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- Dus Series EUDAMEDThe one device included 100 Strips FDA UDI
- Model / Reference
- 3374 EUDAMEDFDA UDIDUS Series EUDAMED
- Description
- The one device included 100 Strips FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806141304876 EUDAMED08806141303480 FDA UDI
- Basic UDI-DI
- 88061413US33D0JN EUDAMED
- FDA Product Code
- LJX FDA UDIJMT FDA UDICEN FDA UDI
- EMDN Code
- W01010999 MULTIPLE PARAMETERS URINE TESTING - OTHER EUDAMED
- GMDN Term
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 864.7675 FDA UDI862.1510 FDA UDI862.1550 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
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Multiple urine analyte IVD, kit, rapid colorimetric, clinical
One+Step UTI 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 c40564e3-1db0-46e8-bea6-d26ff3a2642e 34 fields · synced Jul 18, 2026
- EUDAMED af167ddc-53bb-4a81-af91-84dbc089e597 61 fields · synced Jul 18, 2026