Identity
- Trade Name
- URiSCAN® 4 HemoGPH strip EUDAMED
- Device Name
- URiSCAN® strip (Professional use) EUDAMED
- Model / Reference
- U12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806125680040 EUDAMED
- Basic UDI-DI
- 88061256USTR-PYR EUDAMED
- EMDN Code
- W0101060204,W0101060205 EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France 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® 4 HemoGPH 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 6f1df71d-71b8-4bad-80e1-27123c623b0b 61 fields · synced Jun 18, 2026