Identity
- Trade Name
- URiSCAN® 10 SGL strip EUDAMEDURiSCAN 10 SGL strip FDA UDI
- Generic Name
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- URiSCAN® strip (Professional use) EUDAMEDUrinalysis dip and read strips for visual and URiSCAN urine analyzer. Test for Blood, Bilirubin, Urobilinogen, Ketones(Acetoacetic Acid), Protein, Nitrite, Glucose, pH, SG(Specific Gravity) and Leucocytes in urine. FDA UDI
- Model / Reference
- U39 EUDAMEDU391 FDA UDI
- Description
- Urinalysis dip and read strips for visual and URiSCAN urine analyzer. Test for Blood, Bilirubin, Urobilinogen, Ketones(Acetoacetic Acid), Protein, Nitrite, Glucose, pH, SG(Specific Gravity) and Leucocytes in urine. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806125680019 EUDAMEDFDA UDI
- Basic UDI-DI
- 88061256USTR-PYR EUDAMED
- 510(k) Number
- K952307 FDA UDI
- FDA Product Code
- JIL FDA UDIJRE FDA UDILJX FDA UDIJMT FDA UDIJJB FDA UDIJIR FDA UDIJIO FDA UDIJIN FDA UDICEN FDA UDICDM FDA UDI
- EMDN Code
- W0101060204,W0101060205 EUDAMED
- GMDN Term
- Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1340 FDA UDI862.2800 FDA UDI864.7675 FDA UDI862.1510 FDA UDI862.1115 FDA UDI862.1645 FDA UDI864.6550 FDA UDI862.1435 FDA UDI862.1550 FDA UDI862.1785 FDA UDI
- Market of Registration
- Czechia 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
Yes
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Multiple urine analyte IVD, kit, rapid colorimetric, clinical
URiSCAN 10 SGL strip by Yd Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Yd Diagnostics
Sources (2)
- FDA UDI bc6732bd-2ca4-480e-a34f-d9f11a3e12b2 34 fields · synced Jul 9, 2026
- EUDAMED 558ddc64-b546-4ae3-82d6-16c3cf64819e 61 fields · synced Jul 9, 2026