Certifications
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:
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
![Guangzhou BioKey Healthy Technology Co.Ltd Certifications]()
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
Company Profile
Guangzhou BioKey Healthy Technology Co.Ltd
Contact Person: MsLisa
