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Quality Management System Certificates & Global Quality Manual

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Design Center and Manufacturing Certificates

 

Americas

Number Type Location Expiry Date Details
FM 748457

ISO 13485:2016

Brazil

February 07, 2028

17622

ISO 13485:2016

USA

July 9, 2027

24161

ISO 13485:2016

USA

July 17, 2025

34438

ISO 13485: 2016 & MDSAP

USA

July 17, 2025

35146-5

ISO 13485: 2016 & MDSAP

USA

December 20, 2027

22243-11

ISO 13485:2016

USA

December 20, 2027

17462

ISO 13485:2016

USA

May 17, 2028

34629

ISO 13485: 2016 & MDSAP

USA

May 17, 2028

11472

ISO 13485:2016

USA

June 10, 2026

FM 649679

ISO 13485:2016

USA

May 26, 2028

MDSAP 758987

MDSAP

USA

May 26, 2028

C2022-00584

ISO 27001:2022

USA

February 2, 2028

Asia Pacific

Number Type Location Expiry Date Details
35146-5

MDSAP

Singapore

December 20, 2027

SG23/00000028

UKAS ISO 13485:2016
UKAS EN ISO 13485:2016

Singapore

June 20, 2026

SG23/00000029

SAC ISO 13485:2016

Singapore

June 20, 2026

28823

ISO 9001:2015

China

June 12, 2026

Europe, Middle East and Africa

Number Type Location Expiry Date Details
9140

ISO 13485:2016

France

December 11, 2027

35058

ISO 13485: 2016 & MDSAP

France

December 11, 2027

FR083372-1

ISO 13485:2016

France

October 22, 2026

1122566

ISO 9001:2015

Israel

November 12, 2026

BE23/00000273

ISO 13485:2016

Belgium

May 9, 2027

20100112006575

ISO 9001:2015
ENGLISH VERSION

Germany

January 9, 2027

20100112006575

ISO 9001:2015
GERMAN VERSION

Germany

January 9, 2027

M-81-a/3/2023

13485:2016-04
ENGLISH VERSION

Poland

July 13, 2026

M-81-a/3/2023

13485:2016-04
POLISH VERSION

Poland

July 13, 2026

M-81-b/3/2023

13485:2016-04
ENGLISH VERSION

Poland

July 13, 2026

M-81-b/3/2023

13485:2016-04
POLISH VERSION

Poland

July 13, 2026

QS6 118577 0016

ISO 13485:2016 & MDSAP
ENGLISH VERSION

Germany

March 22, 2027

QS6 040330 0163

ISO 13485: 2016 & MDSAP

Switzerland

October 2, 2027

Q5 040330 0193

ISO 13485:2016

Switzerland/Germany

October 30, 2027

00185/A/0002/UK/En

ISO 9001:2015

UK

July 19, 2027

Sales Service and Distribution

Americas

Number Type Location Expiry Date Details
17764

ISO 13485:2016
ENGLISH VERSION

Canada

September 21, 2027

17764

ISO 13485:2016
FRENCH VERSION

Canada

September 21, 2027

27516794-9001

ISO 9001:2015

Mexico

September 17, 2026

27516794-13485

ISO 13485:2016

Mexico

September 17, 2026

Asia Pacific

Number Type Location Expiry Date Details
QEC13549

ISO 9001:2015

Australia & New Zealand

November 22, 2028

MD 685143

ISO 13485:2016

China

January 14, 2028

FM 695522

ISO 9001:2015

China

Febuary 24, 2028

01 100 2137578

ISO 9001:2015

India

March 9, 2026

AJAEU/21/16738

ISO 9001:2015

Singapore

July 3, 2027

AJAS21/0172

SS 620:2016 GDP

Singapore

October 5, 2027

SG25/00000057

ISO 13485:2016
EN ISO 13485:2016

Singapore

August 19, 2028

SG25/00000058

ISO 13485:2016

Singapore

August 19, 2028

Europe, Middle East and Africa

Number Type Location Expiry Date Details
066 24 0036 (EN)

ISO 37001:2016

Greece

November 4, 2027

066 24 0036 (GR)

ISO 37001:2016

Greece

November 4, 2027

452886

1348/04 – D3(a)4822/2025

Greece

October 17, 2028

35330/A/0001/ UK/En

ISO 9001:2015

Czech Republic

June 15, 2027

35330.A.0001.UK.Cz

ISO 9001:2015 CZECH VERSION

Czech Republic

June 15, 2027

Q8 119781 0001

ISO 13485:2016

Europe Distribution (France & Germany)

June 21, 2026

FM 635742

ISO 9001:2015

Northern Europe, France, Central Europe & Southern Europe

August 25, 2027

MD 636076

ISO 13485:2016

Northern Europe, France, Central Europe, Southern Europe & South Africa

September 1, 2027

001812 UM15

ISO 14001:2015

Germany

June 17, 2027

89398-2010-AE-SWE-SWEDAC

ISO 14001:2015

Nordics

November 29, 2025

1-2329

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

France

February 28, 2030

2-1951

NF EN ISO/IEC 17025 : 2017 - Temperature

France

February 28, 2030

2-1952

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

France

February 28, 2030

2-1967

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

France

February 28, 2030

23.1334.026

GOST ISO 13485-2017

Russia

November 21, 2026