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Multi-Drug 12 Cassette 25 test (MET/COC/THC/MDMA/MTD/MOP/KET/BZO/AMP/TCA/BAR/OP…
EUDAMEDClass B (EU MDR)
Ref 1-DOA-1125
Identity
- Device Name
- Multi-Drug 12 Cassette 25 test (MET/COC/THC/MDMA/MTD/MOP/KET/BZO/AMP/TCA/BAR/OPI) DOA-1125.. EUDAMED
- Model / Reference
- 1-DOA-1125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05902643959057 EUDAMED
- Basic UDI-DI
- 59026439BRTDOA1125VH EUDAMED
- EMDN Code
- W0102160511 MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Poland 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 12 Cassette 25 test (MET/COC/THC/MDMA/MTD/MOP/KET/BZO/AMP/TCA/BAR/OP… by BioMaxima Spółka Akcyjna — Class B — IVDR — listed in EUDAMED
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 | 59026439BRTDOA1125VH | Class B | Active |
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Manufacturer
- Manufacturer
- BioMaxima Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000039473
Sources (1)
- EUDAMED 1be8edc2-1141-46dd-9286-1e92a3692c53 61 fields · synced Oct 6, 2026