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Multi-Drug 12 Cassette 25 tests (MET/ COC/ THC/ MDMA/ MTD/ MOP/ PCP/ BZO/ AMP/ …
EUDAMEDClass B (EU MDR)
Ref 1-DOA-1125 012
Identity
- Device Name
- Multi-Drug 12 Cassette 25 tests (MET/ COC/ THC/ MDMA/ MTD/ MOP/ PCP/ BZO/ AMP/ TCA/ BAR/ OPI) / 1-DOA-1125 012 EUDAMED
- Model / Reference
- 1-DOA-1125 012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05902643959200 EUDAMED
- Basic UDI-DI
- 59026439BRTDOA1125012T5 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 tests (MET/ COC/ THC/ MDMA/ MTD/ MOP/ PCP/ BZO/ AMP/ … 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 | 59026439BRTDOA1125012T5 | Class B | Active |
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Manufacturer
- Manufacturer
- BioMaxima Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000039473
Sources (1)
- EUDAMED 57b902ce-8763-492a-8926-8fed892449e4 61 fields · synced Oct 6, 2026