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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