Guangzhou BioKey Healthy Technology Co.Ltd quality control

Standard:US FDA Registration

Number:N/A

Issue Date:2024-01-03

Expiry Date:2024-12-31

Scope/Range:US and other countries except Europe

Issued By:US FDA

Standard:CE 1

Number:ECREP 20220119.26

Issue Date:2022-01-19

Expiry Date:2025-03-28

Scope/Range:IVD-Directive 98/79

Issued By:CMC Medical Devices&Drugs S.L.

Standard:CE approved product listing 1

Number:ECREP 20220119.26

Issue Date:2022-01-19

Expiry Date:2025-03-28

Scope/Range:IVD-Directive 98/79

Issued By:CMC Medical Devices&Drugs S.L.

Standard:CE 2

Number:ECREP 20220520.13

Issue Date:2022-05-20

Expiry Date:2027-03-28

Scope/Range:IVD-Directive 98/79

Issued By:CMC Medical Devices&Drugs S.L.

Standard:CE approved product listing 2

Number:ECREP 20220520.13

Issue Date:2022-05-20

Expiry Date:2027-03-28

Scope/Range:IVD-Directive 98/79

Issued By:CMC Medical Devices&Drugs S.L.

Standard:CE approved product listing 3

Number:ECREP 20220520.13

Issue Date:2022-05-20

Expiry Date:2027-03-28

Scope/Range:IVD-Directive 98/79

Issued By:CMC Medical Devices&Drugs S.L.

Standard:Quality Management System ISO 13485

Number:131032

Issue Date:2025-03-17

Expiry Date:2028-04-07

Scope/Range:molecular testing lines

Issued By:NQA

Standard:NMPA

Number:20223221751

Issue Date:2022-12-20

Expiry Date:2027-12-20

Scope/Range: molecular testing lines

Issued By:Chinese Food and Drug Administration