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:
Quality Management System
Number:
131032
Issue Date:
2022-04-07
Expiry Date:
2025-04-07
Scope/Range:
ISO 13485: 2016
Issued By:
NQA
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
Company Profile
Guangzhou BioKey Healthy Technology Co.Ltd
Contact Person: MsLisa
