6 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Sweden
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Pro-Options AB
Manufacturer
🇸🇪 Sweden
TM-PC PRO
Basic UDI-DI
EU MDR
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Eu Md Class 1
·Europea i Malmö AB·1 device
Coala Heart Monitor Pro
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Coala Life AB·1 device
Coala Heart Monitor pro EU
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Coala Life AB·1 device
Breas Medical AB
Importer
🇸🇪 Sweden·4 Manufacturers
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
FDA Enforcement
Class II
·Terminated·ELEKTA SOLUTIONS AB·October 20, 2021