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One Step HCG Pregnancy Test
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref ABT-FT-C1Model MidstreamRef ABT-FT-A1Model Strip
Identity
- Trade Name
- One Step HCG Pregnancy Test EUDAMED
- Device Name
- One Step HCG Pregnancy Test EUDAMED
- Model / Reference
- Midstream EUDAMEDABT-FT-C1 EUDAMEDStrip EUDAMEDABT-FT-A1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ABT-FT-C123 EUDAMEDD-ABT-FT-A1ZS EUDAMED
- Basic UDI-DI
- B-ABT-FT-C123 EUDAMEDB-ABT-FT-A1ZS EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing 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
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
One Step HCG Pregnancy Test by AccuBioTech Co., Ltd. — Class IVD devices for self-testing — 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-C123 | Class IVD devices for self-testing | 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 893d8021-8451-4545-92f0-c3f366f53092 61 fields · synced Sep 18, 2026
- EUDAMED 1ba7478f-13f0-4483-96e7-a3c680154015 61 fields · synced May 18, 2026