FDA.report

GENEA BIOMEDX Pty Ltd.

Matched from indexed company URL: Genea Biomedx Pty Ltd

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30128537043012853704GENEA BIOMEDX Pty Ltd.1N2026-01-01level2, 321 Kent Street Sydney New South Wales AU 2000

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1974681930842807K180304Geri Embryo Incubator and Geri DishMQG2018-04-20
1974681930842807K180304Geri Embryo Incubator and Geri DishMQG2018-04-20
1974681148338173K180188Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri DishMQG2018-06-07
1974681148338173K180188Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri DishMQG2018-06-07
1974681766260509K171736Geri Embryo Incubator and Geri DishMQG2017-11-15
1974681766260509K171736Geri Embryo Incubator and Geri DishMQG2017-11-15
1974681115074718K170498Gems Oocyte Retrieval Buffer ORB-20, ORB-50MQL2017-09-28
1974681115074718K170498Gems Oocyte Retrieval Buffer ORB-20, ORB-50MQL2017-09-28
1974681970885890K162409Gems Vitrification Set, Gems Warming SetMQL2017-05-24
1974681970885890K162409Gems Vitrification Set, Gems Warming SetMQL2017-05-24
1974681540937482K161261Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBaseMQL2017-05-12
1974681540937482K161261Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBaseMQL2017-05-12

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
MQG62018-06-07
MQL62017-09-28

PMA

PMN

Applications

GUDID