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Biocanto Test ciazowy
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref ACK21001-M01-015Model MidstreamRef ACK21002-C01-029Model Cassette
Identity
- Trade Name
- Biocanto Test ciazowy EUDAMEDBiocanto Test ciazowy EUDAMED
- Device Name
- HCG Pregnancy Tests EUDAMED
- Model / Reference
- Midstream EUDAMEDACK21001-M01-015 EUDAMEDCassette EUDAMEDACK21002-C01-029 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942468134993 EUDAMED06942468134986 EUDAMED
- Basic UDI-DI
- B-06942468134993 EUDAMEDB-06942468134986 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
Biocanto Test ciazowy 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-06942468134993 | 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 (2)
- EUDAMED ee15ee41-bc96-4e1b-9d75-66ad02a5fb2e 61 fields · synced Jul 13, 2026
- EUDAMED d296da7b-f344-4511-85b0-f94dbcd1446a 61 fields · synced May 19, 2026