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Accu-Tell® Adulteration Strip (Urine)
EUDAMEDClass IVD General (EU MDR)
Ref ABT-DOA-A335Model StripRef ABT-DOA-A382
Identity
- Trade Name
- Accu-Tell® Adulteration Strip (Urine) EUDAMED
- Device Name
- Accu-Tell® Adulteration Strip (Urine) EUDAMED
- Model / Reference
- Strip EUDAMEDABT-DOA-A335 EUDAMEDABT-DOA-A382 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970581432009 EUDAMEDD-ABT-DOA-A382QL EUDAMED
- Basic UDI-DI
- B-06970581432009 EUDAMEDB-ABT-DOA-A382QL EUDAMED
- EMDN Code
- W0102160599 DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER 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
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® Adulteration Strip (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-06970581432009 | 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 acc50e9f-16a0-43fb-90bb-fcdabccc3842 61 fields · synced Jul 21, 2026
- EUDAMED 9ff009ed-eac2-432c-a2e8-540d1b48ab97 61 fields · synced May 19, 2026