653955

Certificate

AIMDD Annex II Section 4·Saluda Medical Pty Ltd·BSI Group The Netherlands B.V.·4 Basic UDI-DIs

541873 MR2

Certificate

MDD Annex II (excluding section 4)·RRR Manufacturing Pty Ltd·DQS Medizinprodukte GmbH·1 Basic UDI-DI

MRA Q00068

Certificate

MDD Annex II (excluding section 4)·Ellex Medical Pty Ltd·THERAPEUTIC GOODS ADMINISTRATION·15 Basic UDI-DIs

CE694938

Certificate

MDD Annex V·Kesem Health Pty Ltd·BSI Group The Netherlands B.V.·1 Basic UDI-DI

CardioMobile

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Oy Diagnostic Devices Development·1 device

Smartz Operations Pty Ltd

System producer

🇦🇺 Australia

fi medikal ltd.sti

Authorized representative

🇹🇷 Türkiye

SANGUESA SA

Importer

🇪🇸 Spain·10 Manufacturers

Fairmont Medical Products Pty Ltd

System producer

🇦🇺 Australia

Trajan Scientific Australia Pty Ltd

System producer

🇦🇺 Australia

NATECH

Importer

🇫🇷 France·11 Manufacturers

Mertz Eyewear Siołkowski Sp.K.

Importer

🇵🇱 Poland·10 Manufacturers

AfibAlert

FDA UDI

LOHMAN TECHNOLOGIES, LLC·00860003939703·The AfibAlert® is a cardiac event recorder capa...

AfibAlert / hom ecg+

FDA UDI

LOHMAN TECHNOLOGIES, LLC·00860003939734·The hom ecg+ / AfibAlert® is a cardiac event r...

BIOSYNEX

Importer

🇫🇷 France·19 Manufacturers

MDSS GmbH

Authorized representative

🇩🇪 Germany·388 Manufacturers·16562 Devices

CD8 [SP16] 0.1mL

FDA registration

Microgenics Corporation·1 product·🇺🇸 United States

Villin [CWWB1] 0.5mL

FDA registration

RICHARD-ALLAN SCIENTIFIC LLC·1 product·🇺🇸 United States

Platinum

FDA UDI

SUMMUS MEDICAL LASER, LLC·B679SLP4H0·Light weight (~2.5 Kg.) and portable therapeuti...

SUNGO Europe B.V.

Authorized representative

🇳🇱 Netherlands·1571 Manufacturers·20390 Devices