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Quality Management System Certificates & Global Quality Manual

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Design Center and Manufacturing Certificates

 

Americas

NumberTypeLocationExpiry DateDetails
FM 748457ISO 13485:2016BrazilFebruary 07, 2028
17622ISO 13485:2016USAJuly 9, 2027
24161ISO 13485:2016USAJuly 17, 2028
34438ISO 13485: 2016 & MDSAPUSAJuly 17, 2028
35146-5ISO 13485: 2016 & MDSAPUSADecember 20, 2027
22243-11ISO 13485:2016USADecember 20, 2027
17462ISO 13485:2016USAMay 17, 2028
34629ISO 13485: 2016 & MDSAPUSAMay 17, 2028
11472ISO 13485:2016USAJune 10, 2026
FM 649679ISO 13485:2016USAMay 26, 2028
MDSAP 758987MDSAPUSAMay 26, 2028
C2022-00584ISO 27001:2022USAFebruary 2, 2028

Asia Pacific

NumberTypeLocationExpiry DateDetails
35146-5MDSAPSingaporeDecember 20, 2027
SG23/00000028UKAS ISO 13485:2016
UKAS EN ISO 13485:2016
SingaporeJune 20, 2026
SG23/00000029SAC ISO 13485:2016SingaporeJune 20, 2026
28823ISO 9001:2015ChinaJune 12, 2026

Europe, Middle East and Africa

NumberTypeLocationExpiry DateDetails
9140ISO 13485:2016FranceDecember 11, 2027
35058ISO 13485: 2016 & MDSAPFranceDecember 11, 2027
FR083372-1ISO 13485:2016FranceOctober 22, 2026
1122566ISO 9001:2015IsraelNovember 12, 2026
BE23/00000273ISO 13485:2016BelgiumMay 9, 2027
20100112006575ISO 9001:2015
ENGLISH VERSION
GermanyJanuary 9, 2027
20100112006575ISO 9001:2015
GERMAN VERSION
GermanyJanuary 9, 2027
M-81-a/3/202313485:2016-04
ENGLISH VERSION
PolandJuly 13, 2026
M-81-a/3/202313485:2016-04
POLISH VERSION
PolandJuly 13, 2026
M-81-b/3/202313485:2016-04
ENGLISH VERSION
PolandJuly 13, 2026
M-81-b/3/202313485:2016-04
POLISH VERSION
PolandJuly 13, 2026
QS6 118577 0016ISO 13485:2016 & MDSAP
ENGLISH VERSION
GermanyMarch 22, 2027
QS6 040330 0163ISO 13485: 2016 & MDSAPSwitzerlandOctober 2, 2027
Q5 040330 0193ISO 13485:2016Switzerland/GermanyOctober 30, 2027
00185/A/0002/UK/EnISO 9001:2015UKJuly 19, 2027

Sales Service and Distribution

Americas

NumberTypeLocationExpiry DateDetails
17764ISO 13485:2016
ENGLISH VERSION
CanadaSeptember 21, 2027
17764ISO 13485:2016
FRENCH VERSION
CanadaSeptember 21, 2027
27516794-9001ISO 9001:2015MexicoSeptember 17, 2026
27516794-13485ISO 13485:2016MexicoSeptember 17, 2026

Asia Pacific

NumberTypeLocationExpiry DateDetails
QEC13549ISO 9001:2015Australia & New ZealandNovember 22, 2028
MD 685143ISO 13485:2016ChinaJanuary 14, 2028
FM 695522ISO 9001:2015ChinaFebuary 24, 2028
01 100 2137578ISO 9001:2015IndiaMarch 9, 2026
AJAEU/21/16738ISO 9001:2015SingaporeJuly 3, 2027
AJAS21/0172SS 620:2016 GDPSingaporeOctober 5, 2027
SG25/00000057ISO 13485:2016
EN ISO 13485:2016
SingaporeAugust 19, 2028
SG25/00000058ISO 13485:2016SingaporeAugust 19, 2028

Europe, Middle East and Africa

NumberTypeLocationExpiry DateDetails
066 24 0036 (EN)ISO 37001:2016GreeceNovember 4, 2027
066 24 0036 (GR)ISO 37001:2016GreeceNovember 4, 2027
4528861348/04 – D3(a)4822/2025GreeceOctober 17, 2028
35330/A/0001/ UK/EnISO 9001:2015Czech RepublicJune 15, 2027
35330.A.0001.UK.CzISO 9001:2015 CZECH VERSIONCzech RepublicJune 15, 2027
Q8 119781 0001ISO 13485:2016Europe Distribution (France & Germany)June 21, 2026
FM 635742ISO 9001:2015Northern Europe, France, Central Europe & Southern EuropeAugust 25, 2027
MD 636076ISO 13485:2016Northern Europe, France, Central Europe, Southern Europe & South AfricaSeptember 1, 2027
001812 UM15ISO 14001:2015GermanyJune 17, 2027
89398-2010-AE-SWE-SWEDACISO 14001:2015NordicsNovember 29, 2028
1-2329NF EN ISO/IEC 17025 : 2017 - Industrial equipments and engineering products/ climatic chambers - thermal cyclersFranceFebruary 28, 2030
2-1951NF EN ISO/IEC 17025 : 2017 - TemperatureFranceFebruary 28, 2030
2-1952NF EN ISO/IEC 17025 : 2017 - Time and frequencyFranceFebruary 28, 2030
2-1967NF EN ISO/IEC 17025 : 2017 - Mass and volume /volumeFranceFebruary 28, 2030
23.1334.026GOST ISO 13485-2017RussiaNovember 21, 2026