Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring

FDA classification

FDA Not Classified ·Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring

tz-gesundheit GmbH&Co.KG

Importer

🇩🇪 Germany

FI20/07011

Certificate

MDD Annex II (excluding section 4)·QT Medical, Inc.·SGS FIMKO OY·1 Basic UDI-DI

CentriMag Pre-connected Pack

FDA registration

APPLIMED SA -CSSR·7 products·🇨🇭 Switzerland

CentriMag Pre-connected Pack

FDA registration

THORATEC CORP.·7 products·🇺🇸 United States

ABBOTT

FDA registration

CENTERPIECE S. DE R.L DE C.V (sterilization site)·7 products·🇲🇽 Mexico

INSPIRE

FDA UDI

SORIN GROUP ITALIA SRL·08033178113359·

ProtekDuo

FDA UDI

CARDIACASSIST, INC.·00814112020555·TandemHeart Blood Pump Kit with 31 Fr Mini V-V...

INSPIRE

FDA UDI

SORIN GROUP ITALIA SRL·08033178113366·

TandemLife

FDA UDI

CARDIACASSIST, INC.·00814112020524·TandemHeart blood pump,TandemLung Oxygenator,15...

TandemLife

FDA UDI

CARDIACASSIST, INC.·00814112020517·TandemHeart blood pump,TandemLung Oxygenator,17...

TandemLife LifeSPARC

FDA UDI

CARDIACASSIST, INC.·00814112020692·LifeSPARC Blood Pump, TandemLung Oxygenator, 17...

TandemLife LifeSPARC

FDA UDI

CARDIACASSIST, INC.·00814112020708·LifeSPARC Blood Pump, TandemLung Oxygenator, 15...

TandemLung LifeSPARC

FDA UDI

CARDIACASSIST, INC.·00814112020760·LifeSPARC Blood Pump, TandemLung Oxygenator, 31...

TandemLung LifeSPARC

FDA UDI

CARDIACASSIST, INC.·00814112020753·LifeSPARC Blood Pump, TandemLung Oxygenator, 29...

TandemLung LifeSPARC

FDA UDI

CARDIACASSIST, INC.·00814112020777·LifeSPARC Blood Pump, TandemLung Oxygenator, 31...

Maxcert Eurep

Authorized representative

🇩🇪 Germany·65 Manufacturers·8 Devices

KHANG BAO INTERNATIONAL KFT

Authorized representative

🇭🇺 Hungary·119 Manufacturers·1262 Devices

CEpartner4U

Authorized representative

🇳🇱 Netherlands·160 Manufacturers·5787 Devices

MedNet EC-REP GmbH

Authorized representative

🇩🇪 Germany·464 Manufacturers·5263 Devices