46 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Sweden
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Juläine
Basic UDI-DI
EU MDD
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Eu Md Class 3
·Nordberg Medical AB·1 device
LoFric Origo, Nelaton, 16in, FR10 urinary catheters
FDA Enforcement
Class II
·Terminated·Wellspect HealthCare (Division of DENTSPLY IH AB)·July 29, 2020
LoFric Origo, Tiemann, 16in, FR12 urinary catheters
FDA Enforcement
Class II
·Terminated·Wellspect HealthCare (Division of DENTSPLY IH AB)·July 29, 2020
LoFric Origo, Tiemann, 16in, FR14 urinary catheters
FDA Enforcement
Class II
·Terminated·Wellspect HealthCare (Division of DENTSPLY IH AB)·July 29, 2020
301001863DE
Certificate
MDD Annex II Section 4·Nordberg Medical AB·NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY·1 Basic UDI-DI
RISE Research Institutes of Sweden AB
Notified body
🇸🇪 Sweden·4 Manufacturers·14 Basic UDI-DIs