111 results
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18ms
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Sources: EU EUDAMED, US FDA
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Country: Canada
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16 BIT INC
FDA registration
16 BIT INC·1 product·🇨🇦 Canada
The Savaria Stairfriend is a Residential, commercial, indoor, stair lift for curved stairs.
FDA Enforcement
Class II
·Terminated·Savaria Concord Lifts, Inc.·May 3, 2017
Savaria SL-1000 Stairlift
FDA Enforcement
Class II
·Terminated·Savaria Concord Lifts, Inc.·May 17, 2017
Omega Incline Platform Lift
FDA Enforcement
Class II
·Terminated·Savaria Concord Lifts, Inc.·May 3, 2017
ORAgene (Swab-based DNA & Dx Collection Device)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DNA Genotek Inc.·4 devices
Testosterone Saliva ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Diagnostics Biochem Canada Inc.·1 device
Testosterone ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Diagnostics Biochem Canada Inc.·1 device
Resistin ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Diagnostics Biochem Canada Inc.·1 device
Prolactin (PRL) ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Diagnostics Biochem Canada Inc.·1 device
Progesterone ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Diagnostics Biochem Canada Inc.·1 device
Progesterone Saliva ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Diagnostics Biochem Canada Inc.·1 device
Free Estriol ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Diagnostics Biochem Canada Inc.·1 device
Anti-Thyroglobulin (Anti-Tg) ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Diagnostics Biochem Canada Inc.·1 device
INSTI HIV-1/HIV-2 ANTIBODY TEST KIT
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
iSTATIS COVID-19 Ag HOME TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·1 device
iSTATIS COVID-19 Ag HOME TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·1 device
iSTATIS COVID-19 Ag TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·1 device
INSTI COVID ANTIBODY TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·1 device
INSTI HIV ANTIBODY SELF-TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HIV ANTIBODY SELF-TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device