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Evidence MultiSTAT Drugs of Abuse (DOA) ToxPlex Urine Array
EUDAMEDClass C (EU MDR)
Ref EV4505
Identity
- Trade Name
- Evidence MultiSTAT Drugs of Abuse (DOA) ToxPlex Urine Array EUDAMED
- Device Name
- Evidence MultiSTAT Drugs of Abuse (DOA) ToxPlex Urine Array EUDAMED
- Model / Reference
- EV4505 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055273220001 EUDAMED
- Basic UDI-DI
- 50552732CTXPLXU068B8 EUDAMED
- EMDN Code
- W0102090199 DRUGS OF ABUSE - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Northern Ireland 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
Evidence MultiSTAT Drugs of Abuse (DOA) ToxPlex Urine Array by Randox Laboratories Limited — Class C — 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 | 50552732CTXPLXU068B8 | Class C | Active |
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Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (1)
- EUDAMED 7ec83a86-d1ea-453b-a868-0689a16cca46 61 fields · synced Jun 17, 2026