Lomina

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
Lomina AG

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Withdrawn on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