Certificate verification page
Certification scheme
98/79/EC Annex III section 6
Certificate number
EC20 0090 2020 0323 rev.2
Certificate history
EC20 0090 2020 0323 rev.2 (Revision 2 | 3.December.2021)
EC20 0090 2020 0323 rev.1 (Revision 1 | 5.Mar.2021-2.December.2021)
EC20 0090 2020 0323 (Initial issue | 15.Dec.2020)
Manufacturer/Holder of certificate
Oberer Gansbach 1, 9050 Appenzell, Switzerland
Other sites
Effective from
3.December.2021
Valid until
26.May.2022
Suspension period
–
Withdrawn on
–
Validity status
Expired
Validity conditions
The manufacturer has a duty to submit to the Notified body testing results as per established procedure of each manufactured batch prior its releasing.
Products within scope
Fast COVID-19 IgM/IgG Antibody Detection Kit (Colloidal Gold)
RYCHLOTEST COVID-19 IgM/IgG, Souprava pro detekci protilátek (Koloidní zlato)
In vitro diagnostic medical device for detection of IgM and IgG antibodies against SARS-CoV-2 virus in whole blood and for determination of approximate IgG antibody level in whole blood