Quality Management Systems Certificates

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Design Center and Manufacturing Certificates

 

Americas

Number Type Location Expiry Date Details
FM 748457

ISO 13485:2016

Brazil

February 07, 2025

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17622

ISO 13485:2016

USA

July 8, 2024

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27471

ISO 13485:2016

USA

August 11, 2025

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35906

ISO 13485: 2016 & MDSAP

USA

August 11, 2025

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39323

NF EN ISO 13485:2016

USA

August 11, 2025

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24161

ISO 13485:2016

USA

July 17, 2025

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34438

ISO 13485: 2016 & MDSAP

USA

July 17, 2025

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35146

ISO 13485: 2016 & MDSAP

USA

December 20, 2024

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22243

ISO 13485:2016

USA

December 20, 2024

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17462

ISO 13485:2016

USA

May 17, 2025

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34629

ISO 13485: 2016 & MDSAP

USA

May 17, 2025

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11472

ISO 13485:2016

USA

June 10, 2026

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FM 649679

ISO 13485:2016

USA

May 26, 2026

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C2022-00584

ISO 27001:2013

USA

February 2, 2025

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Asia Pacific

Number Type Location Expiry Date Details
35146-2

MDSAP

Singapore

December 20, 2024

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SG23/00000028

UKAS ISO 13485:2016
UKAS EN ISO 13485:2016

Singapore

June 20, 2026

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SG23/00000029

SAC ISO 13485:2016

Singapore

June 20, 2026

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28823

ISO 9001:2015

China

June 12, 2026

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Europe, Middle East and Africa

Number Type Location Expiry Date Details
9140

ISO 13485:2016

France

December 11, 2024

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FR083371-1

ISO 9001:2015

France

October 22, 2026

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FR083372-1

ISO 13485:2016

France

October 22, 2026

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108965

ISO 9001:2015

Israel

January 2, 2025

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20308

ISO 13485:2016

Belgium

September 5, 2024

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35058

ISO 13485: 2016 & MDSAP

France

December 11, 2024

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20100112006575

ISO 9001:2015
ENGLISH VERSION

Germany

January 9, 2024

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20100112006575

ISO 9001:2015
GERMAN VERSION

Germany

January 9, 2024

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M-81-a/3/2023

13485:2016-04
ENGLISH VERSION

Poland

July 13, 2026

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M-81-a/3/2023

13485:2016-04
POLISH VERSION

Poland

July 13, 2026

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M-81-b/3/2023

13485:2016-04
ENGLISH VERSION

Poland

July 13, 2026

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M-81-b/3/2023

13485:2016-04
POLISH VERSION

Poland

July 13, 2026

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MD 3065686 3239276-550

ISO 13485: 2016 & MDSAP
ENGLISH VERSION

Germany

March 22, 2024

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SX 1037243-1

ISO 13485:2016
ENGLISH VERSION

Germany

June 8, 2024

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SX 1037243-1

ISO 13485:2016
GERMAN VERSION

Germany

June 8, 2024

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QS6 040330 0163

ISO 13485: 2016 & MDSAP

Switzerland

October 2, 2024

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Q5 042085 0012

ISO 13485:2016

Switzerland

October 30, 2024

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00185/A/0002/UK/En

ISO 9001:2015

UK

July 19, 2024

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Sales Service and Distribution

Americas

Number Type Location Expiry Date Details
17764

ISO 13485:2016
ENGLISH VERSION

Canada

September 21, 2024

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17764

ISO 13485:2016
FRENCH VERSION

Canada

September 21, 2024

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27516794

ISO 9001:2015

Mexico

September 17, 2026

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Asia Pacific

Number Type Location Expiry Date Details
QEC13549

ISO 9001:2015

Australia & New Zealand

November 22, 2025

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MD 685143

ISO 13485:2016

China

January 14, 2025

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FM 695522

ISO 9001:2015

China

Febuary 24, 2025

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01 100 2137578

ISO 9001:2015

India

March 9, 2026

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AJAEU/21/16738

ISO 9001:2015

Singapore

July 3, 2024

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AJAS21/0172

SS 620:2016 GDP

Singapore

October 5, 2024

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Europe, Middle East and Africa

Number Type Location Expiry Date Details
35330/A/0001/ UK/En

ISO 9001:2015

Czech Republic

June 15, 2024

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35330.A.0001.UK.Cz

ISO 9001:2015 CZECH VERSION

Czech Republic

June 15, 2024

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Q8 119781 0001

ISO 13485:2016

Europe Distribution (France & Germany)

June 21, 2026

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01-21012/23-15615 HU

ISO 9001:2015
HUNGARIAN VERSION

Hungary

November 30, 2026

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01-21012/23-15615 EN

ISO 9001:2015
ENGLISH VERSION

Hungary

November 30, 2026

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FM 635742

ISO 9001:2015

Northern Europe, France, Central Europe & Southern Europe

August 25, 2024

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MD 636076

ISO 13485:2016

Northern Europe, France, Central Europe & Southern Europe

September 1, 2024

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001812 UM15

ISO 14001:2015

Germany

June 17, 2024

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89398-2010-AE-SWE-SWEDAC

ISO 14001:2015

Nordics

November 29, 2025

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1-2329

NF EN ISO/IEC 17025 : 2017 - Industrial equipments and engineering products/ climatic chambers - thermal cyclers

France

March 31, 2025

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2-1951

NF EN ISO/IEC 17025 : 2017 - Temperature

France

March 31, 2025

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2-1952

NF EN ISO/IEC 17025 : 2017 - Time and frequency

France

March 31, 2025

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2-1967

NF EN ISO/IEC 17025 : 2017 - Mass and volume /volume

France

March 31, 2025

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