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beibi TEST
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref ACK21001-C01-009Model CassetteRef ACK21002-C01-011Ref ACK21001-M01-009Model Midstream
Identity
- Trade Name
- beibi TEST EUDAMED
- Device Name
- HCG Pregnancy Tests EUDAMED
- Model / Reference
- Cassette EUDAMEDACK21001-C01-009 EUDAMEDACK21002-C01-011 EUDAMEDMidstream EUDAMEDACK21001-M01-009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942468134566 EUDAMED06942468134559 EUDAMED06942468134535 EUDAMED
- Basic UDI-DI
- B-06942468134566 EUDAMEDB-06942468134559 EUDAMEDB-06942468134535 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
beibi TEST by Core Technology 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-06942468134566 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Core Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000023522
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (3)
- EUDAMED c50abf14-ce5b-43f8-aec6-8cc0ba5187ad 61 fields · synced Jul 22, 2026
- EUDAMED b7060967-0a1c-43c4-b67c-84ae77a0674e 61 fields · synced May 19, 2026
- EUDAMED 9274074a-7210-49c4-a71a-98dae68b9ec8 61 fields · synced May 19, 2026