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URiSCAN PluScope Reagent A
EUDAMEDClass IVD General (EU MDR)
Ref USP04-1Model URiSCAN PluScope Reagent A
Identity
- Trade Name
- URiSCAN PluScope Reagent A EUDAMED
- Device Name
- URiSCAN PluScope Reagent A EUDAMED
- Model / Reference
- URiSCAN PluScope Reagent A EUDAMEDUSP04-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806125620862 EUDAMED
- Basic UDI-DI
- B-08806125620862 EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Poland 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
URiSCAN PluScope Reagent A by YD Diagnostics CORP. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08806125620862 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- YD Diagnostics CORP.
- EUDAMED SRN
- KR-MF-000023981
- Authorised Representative
- CARE diagnostica Laborreagenzien GmbH DE-AR-000050899
Sources (1)
- EUDAMED 70424a8e-e1fd-470a-b7e0-caa2ce4315d3 61 fields · synced Jun 19, 2026