16 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Germany
×
QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)
FDA 510(k)
FDA Class 2
·Anesthesiology
orthogold100
Device
EU MDR
·
Eu Md Class 2b
·MTS Medical AG (Aktiengesellschaft)·On the market·5 countries
orthogold100
Device
EU MDR
·
Eu Md Class 2b
·MTS Medical AG (Aktiengesellschaft)·On the market·5 countries
urogold100
Device
EU MDR
·
Eu Md Class 2b
·MTS Medical AG (Aktiengesellschaft)·On the market·5 countries
dermagold100
Device
EU MDR
·
Eu Md Class 2b
·MTS Medical AG (Aktiengesellschaft)·On the market·5 countries
dermagold100
Device
EU MDR
·
Eu Md Class 2b
·MTS Medical AG (Aktiengesellschaft)·On the market·5 countries
OW100S
Device
EU MDR
·
Eu Md Class 2b
·MTS Medical AG (Aktiengesellschaft)·On the market·5 countries
orthogold280
Device
EU MDR
·
Eu Md Class 2b
·MTS Medical AG (Aktiengesellschaft)·On the market·5 countries
urogold100
Device
EU MDR
·
Eu Md Class 2b
·MTS Medical AG (Aktiengesellschaft)·On the market·5 countries
orthogold280
Basic UDI-DI
EU MDR
·
Eu Md Class 2b
·MTS Medical AG (Aktiengesellschaft)·1 device
OW100/OW100S
Basic UDI-DI
EU MDR
·
Eu Md Class 2b
·MTS Medical AG (Aktiengesellschaft)·7 devices
MTS Medizintechnische Servicegesellschaft mbH
Importer
🇩🇪 Germany·1 Manufacturer
Polmed.de Beata Rozwadowska
Authorized representative
🇩🇪 Germany·7 Manufacturers·1 Device
Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterile
FDA Enforcement
Class II
·Ongoing·Spiggle & Theis Mt Gmbh·August 27, 2025
MTS Medizintechnische Servicegesellschaft mbH
System producer
🇩🇪 Germany
Nilas MV GmbH
Authorized representative
🇩🇪 Germany·1 Manufacturer·4 Devices