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EUDAMED last updated this device on May 13, 2026
B-06957290300126HCG-S3.5 is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Self-testing. Manufactured by Hubei MEIBAO Biotechnology Co., Ltd. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06957290300126B-06957290300126HCG-S3.5(01)06957290300126
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102160302HCG - RT & POC1 warning recorded — scroll inside the panel to see all entries.
CW275No certificate specifically references this device's Basic UDI-DI.
Primary placement in Netherlands; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Still on market |
CN-MF-000019986No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.V1 084924 0002