CENTAURI Cable Adapter

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Galvanize Therapeutics, Inc.·1 device

Compatibility Cable, BW ThermoCool ST

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Galvanize Therapeutics, Inc.·1 device

CENTAURI Generator

Basic UDI-DI

EU MDR · Eu Md Class 2b ·Galvanize Therapeutics, Inc.·1 device

RheOx Catheter

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Galvanize Therapeutics, Inc.·1 device

RheOx Catheter

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Galvanize Therapeutics, Inc.·1 device

RheOx Generator

Basic UDI-DI

EU MDD · Eu Md Class 2b ·Galvanize Therapeutics, Inc.·1 device

36050

Certificate

MDD Annex II (excluding section 4)·Ablative Solutions Inc.·GMED SAS·2 Basic UDI-DIs

G1 003180 0006

Certificate

MDD Annex II (excluding section 4)·Allurion Technologies Inc. ·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs

G10031800006

Certificate

MDD Annex II (excluding section 4)·Allurion Technologies Inc. ·TÜV SÜD Product Service GmbH·5 Basic UDI-DIs

G100318000006

Certificate

MDD Annex II (excluding section 4)·Allurion Technologies Inc. ·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

3829984TD01

Certificate

MDR Technical Documentation·Cardiac Dimensions, Inc.·DEKRA Certification B.V.·1 Basic UDI-DI

251403-2017-CE-NOR-NA-PS

Certificate

MDD Annex II (excluding section 4)·Venclose, Inc.·DNV Product Assurance AS·3 Basic UDI-DIs

3804606CE01

Certificate

MDD Annex II (excluding section 4)·CytoSorbents Inc.·DEKRA Certification B.V.·2 Basic UDI-DIs

2107466DE02

Certificate

MDD Annex II Section 4·Aziyo Biologics, Inc.·DEKRA Certification B.V.·3 Basic UDI-DIs

2107466DE03

Certificate

MDD Annex II Section 4·Aziyo Biologics, Inc.·DEKRA Certification B.V.·1 Basic UDI-DI

2107466DE01

Certificate

MDD Annex II Section 4·Aziyo Biologics, Inc.·DEKRA Certification B.V.·2 Basic UDI-DIs

2107466CE02

Certificate

MDD Annex II Section 4·Aziyo Biologics, Inc.·DEKRA Certification B.V.·5 Basic UDI-DIs

Biosafety Cabinet SMI-163ANMD2

FDA registration

S.M. SCIENTIFIC INSTRUMENTS PVT. LTD. Jindal manufacturing facility·1 product·🇮🇳 India

XBP4525H

FDA registration

DENTIUM CO., LTD.·1 product·🇰🇷 South Korea

37792

Certificate

MDD Annex II Section 4·CenterPoint Systems LLC·GMED SAS·4 Basic UDI-DIs