Identity
- Trade Name
- URiSCAN Optima FDA UDI
- Generic Name
- Urine analyser IVD, laboratory, semi-automated FDA UDI
- Device Name
- URiSCAN Optima EUDAMEDThe URiSCAN Optima urine chemistry test system consists of URiSCAN Optima Urine analyzer and URiSCAN urine test strips. The intended use of the URiSCAN Optima Urine analyzer is to read the color change on the test pads found on the URiSCAN urine test strips and to display and print the results. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. FDA UDI
- Model / Reference
- M7 EUDAMEDOptima FDA UDI
- Description
- The URiSCAN Optima urine chemistry test system consists of URiSCAN Optima Urine analyzer and URiSCAN urine test strips. The intended use of the URiSCAN Optima Urine analyzer is to read the color change on the test pads found on the URiSCAN urine test strips and to display and print the results. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806125619033 EUDAMEDFDA UDI
- Basic UDI-DI
- 88061256M7CZ EUDAMED
- Direct Marketing DI
- 08806125619033 EUDAMED
- 510(k) Number
- K141874 FDA UDI
- FDA Product Code
- KQO FDA UDI
- EMDN Code
- W02010701 URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS EUDAMED
- GMDN Term
- Urine analyser IVD, laboratory, semi-automated FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2900 FDA UDI
- Market of Registration
- Lithuania EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
URiSCAN Optima by YD Diagnostics CORP. — Class A — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141874 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 88061256M7CZ | Class A | Active |
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Manufacturer
- Manufacturer
- YD Diagnostics CORP.
- EUDAMED SRN
- KR-MF-000023981
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (3)
- EUDAMED 460609e1-6c9e-4c4f-8842-49df750db43c 61 fields · synced Jul 22, 2026
- FDA UDI 760c5dbf-d88f-41da-92b2-ce3b2770a1b6 34 fields · synced May 30, 2026
- FDA 510(k) K141874 1 fields · synced May 18, 2026