CERTIFICATEThe Certification Body

of TÜV SÜD Landesgesellschaft Österreich GmbH

certifies that

BIOMEDICA GRUPPEDivischgasse 4

1210 WienAustria

including the sites see enclosure

has established and appliesa Management System for

Research, Production, Trade, Service and Customer Servicein the Area of in vitro Diagnostics, Research Reagents and

Medical Devices under GLP and GMP Guidelines

An audit was performed, Report No. 153682

Proof has been furnished that the requirementsaccording to

ISO 9001 : 2015

are fulfilled. The certificate is valid until 2022-08-31

Certificate Registration No. Q1530510

Vienna, 2019-08-26

Certification Bodyof TÜV SÜD Landesgesellschaft Österreich GmbH

Franz-Grill-Straße 1 · Arsenal, Objekt 207, 1030 Vienna, Austria

Enclosure 1 / 2 of Certificate No.:

Q1530510

The scope of application for

BIOMEDICA GRUPPEDivischgasse 4

1210 WienAustria

comprises the sites

Site Scope of Application

BIOMEDICA Medizinprodukte GmbHDivischgasse 4A-1210 Wien

Research, Production, Trade, Service andCustomer Service in the Area of in vitro

Diagnostics, Research Reagents and MedicalDevices under GLP and GMP Guidelines

BIOMEDICA Slovakia s.r.o.Drobného 27

SK-84102 Bratislava

Production, Trade, Service and CustomerService in the Area of in vitro Diagnostics,Research Reagents and Medical Devices

under GMP Guidelines

BIOMEDICA Hungária Kft.Ganz utca 16

H-1027 Budapest

Trade, Service and Customer Service in theArea of in vitro Diagnostics, Research

Reagents and Medical Devices

BIOMEDICA CS, s.r.o.

Radlická 740/113dJinonice

CZ-158 00 Praha 5

Podnásepní 375/1CZ-602 00 Brno

Trade, Service and Customer Service in theArea of in vitro Diagnostics, Research

Reagents and Medical Devices

BIOMEDICA POLAND Sp.z.oo.Ul. Raszynska 13

PL-05-500 Piaseczno

Trade, Service and Customer Service in theArea of in vitro Diagnostics, Research

Reagents and Medical Devices

Vienna, 2019-08-26

Certification Bodyof TÜV SÜD Landesgesellschaft Österreich GmbH

Franz-Grill-Straße 1 · Arsenal, Objekt 207, 1030 Vienna, Austria

Enclosure 2 / 2 of Certificate No.:

Q1530510

The scope of application for

BIOMEDICA GRUPPEDivischgasse 4

1210 WienAustria

comprises the sites

Site Scope of Application

BIOMEDICA MP d.o.oLazara Mamuzica 26A

SRB-11080 Zemun

Trade, Service and Customer Service in theArea of in vitro Diagnostics, Research

Reagents and Medical Devices

BIOMEDIS M.B. d.o.o.Slokanova 12

SLO-2000 Maribor

Trade, Service and Customer Service in theArea of in vitro Diagnostics, Research

Reagents and Nuclear Medicine

BIOMEDICA Bulgaria Ltd.Business center “Serdika”

2E “Akad. Ivan E. Geshov” blvd.,build.2, floor 2, office 203

BG-1330 Sofia

Trade, Service and Customer Service in theArea of in vitro Diagnostics, Research

Reagents and Medical Devices

Biomedica Dijagnostika d.o.o.Stojarska cesta 20HR-10000 Zagreb

Trade, Service and Customer Service in theArea of in vitro Diagnostics, Research

Reagents and Medical Devices

Biomedica Medizinprodukte Romania SRLStrada Siriului nr. 42-46, et. 2, Sector 1

RO-014354 Bucharest

Trade, Service and Customer Service in theArea of in vitro Diagnostics, Research

Reagents and Medical Devices

Biomedica d.o.o. Sarajevoul. Tvornicka broj 3

BIH-71210 Ilidža, Sarajevo

Trade, Service and Customer Service in theArea of in vitro Diagnostics, Research

Reagents and Medical Devices

Biomedika Dijagnostika dooelUl. Ilindenska, br. 103 lokal 2 i 3

MKD-1000 Skopje

Trade, Service and Customer Service in theArea of in vitro Diagnostics, Research

Reagents and Medical Devices

Vienna, 2019-08-26

Certification Bodyof TÜV SÜD Landesgesellschaft Österreich GmbH

Franz-Grill-Straße 1 · Arsenal, Objekt 207, 1030 Vienna, Austria