11 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Israel
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MeMed Diagnostics Ltd.
Manufacturer
🇮🇱 Israel·4 Basic UDI-DIs·4 Devices·1 Importer
Nucleix
Manufacturer
🇮🇱 Israel
MeMed BV® External Control
Device
EU IVDR
·
Eu Ivd Class B
·MeMed Diagnostics Ltd.·On the market·4 countries
MeMed BV® Calibrator
Device
EU IVDR
·
Eu Ivd Class B
·MeMed Diagnostics Ltd.·On the market·4 countries
MeMed BV®
Device
EU IVDR
·
Eu Ivd Class B
·MeMed Diagnostics Ltd.·On the market·4 countries
MeMed Key®
Device
EU IVDR
·
Eu Ivd Class A
·MeMed Diagnostics Ltd.·On the market·0 countries
Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze, model C. It is intended to provide increased mobility for elderly and/or disabled person and it is also an aid to independent living. Products can be identified by their color; the recalled products are either metallic blue or metallic silver. The products have two rear wheels and have either one or two wheels in the front. The scooters have an adjustable swivel seat and a front storage basket; some scooters may be fitted with an optional larger rear basket.
FDA Enforcement
Class II
·Terminated·S.A.E. AFIKIM·November 6, 2013
MeMed BV® External Control
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·MeMed Diagnostics Ltd.·1 device
MeMed BV® Calibrator
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·MeMed Diagnostics Ltd.·1 device
MeMed BV®
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·MeMed Diagnostics Ltd.·1 device
MeMed Key®
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·MeMed Diagnostics Ltd.·1 device