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Multi-Drug X Drugs Rapid Test 1-Step Cup with/without Adulteration
EUDAMEDClass IVD General (EU MDR)
Ref DOA-137-A12
Identity
- Trade Name
- Multi-Drug X Drugs Rapid Test 1-Step Cup with/without Adulteration EUDAMED
- Device Name
- Multi-Drug X Drugs Rapid Test 1-Step Cup with/without Adulteration EUDAMED
- Model / Reference
- DOA-137-A12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-DOA-137-A12YU EUDAMED
- Basic UDI-DI
- B-DOA-137-A12YU EUDAMED
- EMDN Code
- W0102160511 MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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
Multi-Drug X Drugs Rapid Test 1-Step Cup with/without Adulteration by ACRO BIOTECH Inc. — Class IVD General — IVDD — listed in EUDAMED
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-DOA-137-A12YU | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Acro Biotech Inc.
- EUDAMED SRN
- US-MF-000017832
- Authorised Representative
- VidaQuick Biotech S.L. ES-AR-000048138
Sources (1)
- EUDAMED ad426e81-b169-4697-9ef9-b11e34238a88 61 fields · synced Sep 30, 2026