Identity
- Trade Name
- URiSCAN® 2 Gluketo strip EUDAMED
- Device Name
- URiSCAN® strip (Professional use) EUDAMED
- Model / Reference
- U24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806125621685 EUDAMED
- Basic UDI-DI
- 88061256USTR-PYR EUDAMED
- EMDN Code
- W0101060204 URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
URiSCAN® 2 Gluketo strip by YD Diagnostics CORP. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 88061256USTR-PYR | Class B | 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 (1)
- EUDAMED 7bd79d20-346d-4c78-8d14-a8d891ca3588 61 fields · synced Jul 9, 2026