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Certificate of Registration
QUALITY MANAGEMENT SYSTEM - ISO 9001:2015

This is to certifu that: Thermo Fisher Scientific Ov

Ratastie 2
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FI-O1620 Vantaa
Finland

Holds Ceftificate No: FM 623250

and operates a Quality Management System which complies with the requirements of ISO 9001:2015 for the
following scope:

Design and development, manufacturing, marketing, sales and service of laboratory products
for research, diagnostic and inrlustrial purposes.

For and on behalf of BSI:

Andrew Launn, EMEA Systems Certification Director

Original Registration Date: 1994-03-31 Effective Date: 2018-02-24

Latest Revision Date: 2018-02-26 Expiry Date: 202L-02-23

Page: 1 of 2

...making excellence a habit"

cERTiFtCAIi0N 8001

online
Certificate No: FM 523250

Location Registered Activities

Thermo Fisher Scientific Oy Design and development, manufacturinE, marketing, sales

Ratastie 2 and service of laboratory products for research, diagnostic
FI-01620 Vantaa and industrial purposes.
Finland Design and development, manufacturing and sales of
molecular biology products for laboratorie$ for research,
industrial and diagnostic purposes.
Design and development, manufacturing, marketing, sales
support and service of liquid handling products, laboratory
instruments and laboratory consumables for research,
industrial purposes and laboratory seruices,

Thermo Fisher Scientific Oy Manufacturing and service of liquid handling products and
Rahtikatu 2 laboratory consumables for research, diagnostic and
FI-80100 Joensuu industrial purposes.
Finland

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Original Registration Date: 1994-03-31 Effective Date: 2018-02-24

Latest Revision Date: 2018-02-26 Expiry Date: 2021-02-23

Page:2 of 2
Ihis certificate w;i-q issuec electronicaiiy und renrarns the pf$perty of S51 and is bound by the r*ndrticns $f {:ontiac1.
An electronic certificate (an be autlenticated online.
Printed copies can be validated at wwyr.bsi-global.comlClientDirertory or telephcne +31 {0120 345il 780.

Information dnd Conttsctl BSI, Kitemark Court, Davy Avefiue, Knowlhill, Mitton Keynes MK5 Bpp. Tel: + 44 j45 {}80 9000
85I Assurance UK Limiied, r*gistered in f;ngland under number 7805321 at 3Bg Chiswick High Road, London W4 4At, UK"
A Member of ihe BSI Group of Cornprnies.
 https://www.bsigroup.com/en-GB/our-services/certification/certificate-and-client-directory/search-results/?
searchkey=licence%3dMD%2b623249%26company%3d

By Royal Charter

Certificate of Registration
QUALITY MANAGEMENT SYSTEM - ISO 13485:2016 & EN ISO 13485:2016

This is to ceftify that: Thermo Fisher Scientific Oy

Ratastie 2
FI-O1620 Vantaa
Finland

Holds Ceftificate Number: MD 623249 ,fr;ty,6.Wa Ukdng 9N,iln

and operates a Quality Management System which complies with the requirements of ISO 13485:2016 & EN ISO
13485:2016 for the following scope:

The design and development, manufacturing, service, installation and distribution of in vitro
diagnostics medical devices including clinical chemistry analysing systems, clinical liquid
chromatography and mass spectrometry systems, laboratory automation and in vitro
diagnostic assays and reagents,

The design and development, manufacture, distribution, sales support and service of in vltro
diagnostic medical instruments, liquid handling products and consumables

For and on behalf of BSI:

/ l* {r'*.
Stewaft Brain, Head of Compliance & Risk - Medical Devices

Original Registration Date: 2012-02-22 Effective Date: 2018-04-01

Latest Revision Date: 2018-03-19 Expiry Date: 2021-03-31

Page: 1 of 2

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Ceftificate No: MD 623249

Location Registered Activities

Thermo Fisher Scientific Oy The design and development, manufacturing, seruice,

Ratastie 2 installation and distribution of in vitro diagnostics medical
FI-O1620 Vantaa devices including clinical chemistry analysing systems, clinical
Finland liquid chromatography and mass spectrometry systems,
laboratory automation and in vitro diagnostic assays and
reagents,
The design and development, manufacture, distribution, sales
support and service of in vitro diagnostic medica
instruments, liquid handling products and consumables.

Thermo Fisher Scientific Oy The manufacture and service of in vitro dipgnostic liquid
Rahtikatu 2 handling products and consumable.
FI-80100 Joensuu
Finland

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Original Registration Date: 2072-02-22 Effective Date: 2018-04-01

Latest Revision Date: 2018-03-19 Expiry Date: 2021-03-31

Page:2 of 2

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