7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Denmark
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Oticon
Device
EU MDR
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Eu Md Class 2a
·SBO Hearing A/S·On the market·27 countries
MedArt ApS
Manufacturer
🇩🇰 Denmark·1 Basic UDI-DI·1 Device·GMED SAS
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
FDA Enforcement
Class II
·Ongoing·NRT X-RAY A/S·May 15, 2024
MedArt 620 FRx Intenz
Device
EU MDD
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Eu Md Class 2b
·MedArt ApS·On the market·3 countries
18166
Certificate
MDD Annex II (excluding section 4)·MedArt ApS·GMED SAS·1 Basic UDI-DI
MedArt 620 FRx Intenz
Basic UDI-DI
EU MDD
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Eu Md Class 2b
·MedArt ApS·1 device
GM Medical A/S
Importer
🇩🇰 Denmark·15 Manufacturers