10 results
·
71ms
·
Sources: EU EUDAMED, US FDA
AventaMed DAC
Manufacturer
🇮🇪 Ireland·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V.
Solo+ TTD
FDA registration
AVENTAMED DAC·1 product·🇮🇪 Ireland
Solo+ TTD
FDA registration
AVENTAMED DAC·1 product·🇮🇪 Ireland
Solo+ Tympanostomy Tube Device (TTD)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Solo+ TTD
Device
EU MDD
·
Eu Md Class 2b
·AventaMed DAC·On the market·3 countries
Solo+ TTD
Device
EU MDD
·
Eu Md Class 2b
·AventaMed DAC·On the market·3 countries
Solo+ Tympanostomy Tube Device
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·AventaMed DAC·1 device
Solo+ Tympanostomy Tube Device
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·AventaMed DAC·1 device
635333
Certificate
MDD Annex II (excluding section 4)·AventaMed DAC·BSI Group The Netherlands B.V.·2 Basic UDI-DIs