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Accu-Tell® D-Dimer Strip (Whole Blood +2 more)
EUDAMEDClass IVD General (EU MDR)
Ref ABT-CT-A110Model Strip
Identity
- Trade Name
- Accu-Tell® D-Dimer Strip (Whole Blood/Plasma/Serum) EUDAMED
- Device Name
- Accu-Tell® Rapid D-Dimer Test EUDAMED
- Model / Reference
- Strip EUDAMEDABT-CT-A110 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ABT-CT-A110L7 EUDAMED
- Basic UDI-DI
- B-ABT-CT-A110L7 EUDAMED
- EMDN Code
- W0103020803 D-DIMER - RT & POC EUDAMED
- Models / Variants
- Whole Blood EUDAMEDPlasma EUDAMEDSerum 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® D-Dimer Strip (Whole Blood +2 more) by AccuBioTech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — 3 models — 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-ABT-CT-A110L7 | 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 (1)
- EUDAMED bdc8164d-3064-462c-8d07-916f2fb965fe 61 fields · synced Oct 6, 2026