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Accu-Tell® Multi-6 Drug Panel (Urine)
EUDAMEDClass IVD General (EU MDR)
Ref ABT-DOA-E32Model Panel
Identity
- Trade Name
- Accu-Tell® Multi-6 Drug Panel (Urine) EUDAMED
- Device Name
- Accu-Tell® Rapid Multi-6 Drug Test EUDAMED
- Model / Reference
- Panel EUDAMEDABT-DOA-E32 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970581431286 EUDAMED06970581430562 EUDAMED
- Basic UDI-DI
- B-06970581431286 EUDAMEDB-06970581430562 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
Yes
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
Accu-Tell® Multi-6 Drug Panel (Urine) by AccuBioTech Co., Ltd. — 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-06970581431286 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- AccuBioTech Co., Ltd.
- EUDAMED SRN
- CN-MF-000025172
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 9e9d6e62-5c07-4ff0-8ffc-f32a28b2c136 61 fields · synced Jul 25, 2026
- EUDAMED 880c7bbf-d21c-4d0a-989f-63f5bb1f69e9 61 fields · synced May 19, 2026