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Accu-Tell® HCG Multi-Line Midstream (Urine)
EUDAMEDClass IVD General (EU MDR)
Ref ABT-FT-C387Model Midstream
Identity
- Trade Name
- Accu-Tell® HCG Multi-Line Midstream (Urine) EUDAMED
- Device Name
- Accu-Tell® HCG Multi-Line Midstream (Urine) EUDAMED
- Model / Reference
- Midstream EUDAMEDABT-FT-C387 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ABT-FT-C387PM EUDAMED
- Basic UDI-DI
- B-ABT-FT-C387PM EUDAMED
- EMDN Code
- W0102160302 HCG - 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® HCG Multi-Line Midstream (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-ABT-FT-C387PM | 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 51edc489-e81b-440c-8ba9-dafd5ac0a49b 61 fields · synced Jun 18, 2026