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Artron Artron Multi-Drug Dip Card Test
EUDAMEDClass IVD General (EU MDR)
Ref A04-18-140Model Dip Card
Identity
- Trade Name
- Artron Artron Multi-Drug Dip Card Test EUDAMED
- Device Name
- Artron Multi-Drug Dip Card Test (DOA-10) EUDAMED
- Model / Reference
- Dip Card EUDAMEDA04-18-140 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00628347563783 EUDAMED
- Basic UDI-DI
- B-00628347563783 EUDAMED
- EMDN Code
- W0102160511 MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania 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
Artron Artron Multi-Drug Dip Card Test by Artron Laboratories Inc. — 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-00628347563783 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Artron Laboratories Inc.
- EUDAMED SRN
- CA-MF-000028974
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED bdc02c19-d853-455b-a167-0745c22e437f 61 fields · synced Jul 14, 2026