Ministry of Health, Welfare and Sport

CIBG
P.O. Box 16114
2500 BC The Hague
THE NETHERLANDS

STATEMENT

The undersigned herewith declares that according to the Decree on In-Vitro Diagnostics, which is
based on the European Directive 98/79/EC concerning in-vitro diagnostic medical devices,

Lotus NL B.V.
Koningin Julianaplein 10
2595 AA 's-Gravenhage
THE NETHERLANDS

acts as authorised representative of the manufacturer.

The manufacturer:

Zybio Inc.
Floor 1 to Floor 5, Building 30, No.6 of Taikang Road, Block C of 3ianqiao Industrial Park,
Dadukou District,
400082 Chongqing
CHINA

is authorised to manufacture and/or supply the medical device/devices mentioned below:

See product list

This device/these devices may be placed on the Dutch market and on the markets of the other
Member States of the European Union, and be exported to non-EU Member States. This free sale
certificate may only be used for export outside the European Union.

The present statement is drawn up at the request of the interested party in order to be submitted
to the Health Authorities of PERU.

This statement is valid until May 26, 2022.

The Hague, April 23, 2021

On behalf of the Minister for Medical Care and Sport

Farnnatec'

e Velde
Mr. M.J. v
Head of Departnnen

Our reference: 20211749

Certificate number: 31695
Product list

Product Name Models

SARS-CoV-2 Neutralizing Antibody Assay (CLIA) 50 T/Kit, 100 T/Kit

SARS-CoV-2 Antibody Assay (CLIA) 50 T/Kit, 100 T/Kit

SARS-CoV-2 Neutralizing Antibody Assay (Colloidal Gold) 20 T/Kit

SARS-CoV-2 Neutralizing Antibody Assay (ELISA) 48 T/Kit, 96 T/Kit

Zybio SARS-CoV-2 Assay Kit 32 T/Kit, 96 T/Kit

Molaccu COVID-19 Detection Kit 32 T/Kit, 96 T/Kit

2019-nCoV Neutralizing Antibody Assay (Colloidal Gold) 20 T/Kit

SARS-CoV-2 Neutralizing Antibody

Assay 25 T/Kit
(Immunaluorescence)

SARS-CoV-2 Antibody Assay (Immunofluorescence) 25 T/Kit