ISO 9001:
International Standard Organization ISO 9001 Certified Quality System

(We canceled it in Oct. 2017)

MDSAP

Medical Device Single Audit Program certification for regulatory compliance supporting the United States and Canada markets.

CE Certification (Historical)

Gemore previously obtained CE certification under the European Medical Devices Directive (MDD) for applicable products.

Although CE certification is no longer maintained following the transition from MDD to MDR, this achievement reflects Gemore's long-standing experience in meeting European medical device regulatory requirements.

PS. MDD CE expired in Oct. 2022.

FDA 510(k)

Selected Gemore products have received FDA 510(k) clearance, allowing legal marketing in the United States.

cTUVus:
The safety certificate of a medical device for Canada and USA.

(We canceled it from initial of 2018.)