Certificate verification page
bqs. s.r.o.
Notified body 2854 | SKTC 180 | Accredited certification body
Certification scheme
EN ISO13485:2016
Certificate number
QMM 24 008 0158
Certificate history
QMM 24 008 0158 (Recertification | 03 June 2024)
QMM 21 013 0097 rev.3 (Revision 3 | 26 June 2023 – Scope extension)
QMM 21 013 0097 rev.2 (Revision 2 | 02 May 2023 – Change of registered address)
QMM 21 013 0097 rev.1 (Revision 1 | 03 October 2021 – Change of scope and company name correction)
QMM 21 013 0097 (Initial issue | 03 June 2021 – 02 October 2022)
Manufacturer/Holder of certificate
500 Mercury Dr. Sunnyvale, CA 94085 USA
Other sites
Effective from
03 June 2024
Suspension period
–
Withdrawn on
–
Validity status
Valid
Scope
Design, development, manufacturing, distribution, and customer service of In-Vitro Diagnostic (IVD) Medical Devices – Noninvasive Prenatal Testing (NIPT), Infectious Disease and Cancer Mutation Assay Detection Kits (NAT)