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이름 분류 제조사 위험등급 국가 출처
Spot-light Tissue Pre-treatment Kit (Antigen retrieval reagent used in cellular imaging). An in vitro diagnostic medical device (IVD). Life Technologies Australia Pty Ltd Australia
Dynabeads HLA (Human Leucocyte Antigen) Class II (an in vitro diagnostic medical device)(reagent used for the isolation of HLA Class II+ cells from human peripheral blood) Life Technologies Australia Pty Ltd Australia
AcroMetrix PeliSpy Sero Control Type 36 and Type 38. An in vitro diagnostic medical device (IVD) Life Technologies Australia Pty Ltd Australia
AK 200 S and AK 200 ULTRA S nocturnal home hemodialysis machines Gambro Pty Ltd Australia
Artis Dialysis System equipped with SW 8.15.06 and 8.33.02 Gambro Pty Ltd Australia
Revaclear and Revaclear Max Dialysers (Hollow-fibre haemodialysis dialyser) Gambro Pty Ltd Australia
Ultrafilter U9000 (Used on Gambro Haemodialysis Delivery Systems.) Gambro Pty Ltd Australia
PRISMA, PRISMAFLEX, X-MARS and ADSORBA sets Gambro Pty Ltd Australia
Gambro Conventional Bloodlines; BL200 BD Pre Post, BL208 BD & BL223PB (dialysis/haemodialysis tubing set)BL200 BD Pre Post Gambro Pty Ltd Australia
Sorin Perceval S Post-Dilation Catheter Size M (indicated for in situ post-dilation of the valve after implantation) Sorin Group Australia Australia
REPLY and ESPRIT Pacemakers interrogated using Orchestra and Orchestra Plus Programmers Sorin Group Australia Australia
ISOLINE 2CR6 and 2CT6 Implantable Defibrillation Leads Cardiovascular Devices Sorin Group Australia Australia
Synapse Cardiovascular (CV) Software Fujifilm Australia Pty Ltd Australia
FUJIFILM General X-ray System FDR Smart f series Fujifilm Australia Pty Ltd Australia
ED-530TK Duodenoscope Fujifilm Australia Pty Ltd Australia
Fujifilm MS Swivel Arm Fujifilm Australia Pty Ltd Australia
Fujifilm Digital Mammography System Fujifilm Australia Pty Ltd Australia
Fujifilm Access Point for FDR Go Flex ­– DR-ID 1200 AP KIT E(Computed radiographic system) Fujifilm Australia Pty Ltd Australia
Fujifilm Synapse PACS software version 4.0, 4.1, 4.2, 4.3 (a picture archiving and communication system) Fujifilm Australia Pty Ltd Australia
Fujifilm ED-530XT Duodenoscope Fujifilm Australia Pty Ltd Australia
Amulet (FDR MS-1000), Amulet f (FDR MS-2500) & Amulet Innovality (FDR MS-3500) with Biopsy Unit Fujifilm Australia Pty Ltd Australia
Synapse Cardiovascular (CV) Client application, version 4.0.8 (Picture archiving and communication system) Fujifilm Australia Pty Ltd Australia
FUJIFILM FDR-1000AWS / FDR-2000AWS / FDR-3000AWS V5.1.0001-0007 with Biopsy unit (a component of FUJIFILM Digital Mammography System) Fujifilm Australia Pty Ltd Australia
Zymed Holter Converter (Cardiology information system designed for the collection and management of electrocardiography data) Fujifilm Australia Pty Ltd Australia
FujiFilm Digital Mammography System AMULET (FDR MS-1000) Fujifilm Australia Pty Ltd Australia