AVVIGO™+

FDA UDI

BOSTON SCIENTIFIC CORPORATION·00191506033170·Multi-Modality Guidance System

Zurich Pressure Guidewire System

FDA UDI

ZURICH MEDICAL INC.·00850022994005·

AVVIGO™+

FDA UDI

BOSTON SCIENTIFIC CORPORATION·00191506033149·Multi-Modality Guidance System

MDU5 PLUS

FDA UDI

BOSTON SCIENTIFIC CORPORATION·08714729982845·Motordrive Unit

AVVIGO™ Guidance System II

FDA UDI

BOSTON SCIENTIFIC CORPORATION·00191506017187·Guidance System

AVVIGO™ Guidance System II

FDA UDI

BOSTON SCIENTIFIC CORPORATION·00191506017224·Guidance System

AVVIGO™ Guidance System II

FDA UDI

BOSTON SCIENTIFIC CORPORATION·00191506015190·Guidance System

AVVIGO™+

FDA UDI

BOSTON SCIENTIFIC CORPORATION·00191506033002·Multi-Modality Guidance System

AVVIGO™ Guidance System II

FDA UDI

BOSTON SCIENTIFIC CORPORATION·00191506015183·Guidance System

Zio® AT Patch

FDA registration

iRhythm Technologies, Inc.·5 products·🇺🇸 United States

Zio® AT Patch

FDA registration

IRHYTHM TECHNOLOGIES, INC.·5 products·🇺🇸 United States

MED MAKS, TRGOVINA IN STORITVE, D.O.O.

Importer

🇸🇮 Slovenia

Computer, Diagnostic, Programmable

FDA classification

FDA Class 2 ·Computer, Diagnostic, Programmable

Binder, Perineal

FDA classification

FDA Class 1 ·Binder, Perineal

MEK-HEALTHCARE-CONSULTING UG

Authorized representative

🇩🇪 Germany

M.2023.MDR.1011

Certificate

MDR QA·MHK MEDİKAL TEKSTİL SAN VE TİC.LTD.ŞTİ·UDEM Adriatic d.o.o.

M.2023.MDR1011

Certificate

MDR QA·MHK MEDİKAL TEKSTİL SAN VE TİC.LTD.ŞTİ·UDEM Adriatic d.o.o.

Right Ventricular Pressure algorithm

FDA registration

BECTON, DICKINSON AND COMPANY·6 products·🇺🇸 United States

HemoSphere ClearSight Module

FDA registration

BECTON, DICKINSON AND COMPANY·6 products·🇺🇸 United States

BENCHMARK ELECTRONICS, INC.

FDA registration

BENCHMARK ELECTRONICS, INC.·6 products·🇺🇸 United States