GENEA BIOMEDX PTY LTD

Address:level2, 321 Kent Street,Sydney New South Wales,AU

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Media, Reproductive (MQL) (9)

Premarket Exempt

Clear

Gems Blastocyst Medium - 09348265005028 Catalog Number :

Device Description : The Gems Blastocyst Medium is intended for culture of embryos from cleavage stag

Device Class : 2

Duns Number: 752103403

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Gems Geri Medium - 09348265005035 Catalog Number :

Device Description : The Gems Geri Medium is intended for culture of embryos from fertilization to bl

Device Class : 2

Duns Number: 752103403

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Gems Fertilisation Medium - 09348265005042 Catalog Number :

Device Description : The Gems Fertilisation Medium is intended for in vitro fertilization and transfe

Device Class : 2

Duns Number: 752103403

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Gems Cleavage Medium - 09348265005059 Catalog Number :

Device Description : The Gems Cleavage Medium is intended for culture of embryos from fertilization t

Device Class : 2

Duns Number: 752103403

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Gems Blastocyst Medium - 09348265005066 Catalog Number :

Device Description : The Gems Blastocyst Medium is intended for culture of embryos from cleavage stag

Device Class : 2

Duns Number: 752103403

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Gems Geri Medium - 09348265005073 Catalog Number :

Device Description : The Gems Geri Medium is intended for culture of embryos from fertilization to bl

Device Class : 2

Duns Number: 752103403

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Gems Vitrification Set - 09348265006032 Catalog Number :

Device Class : 2

Duns Number: 752103403

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Gems Warming Set - 09348265006070 Catalog Number :

Device Class : 2

Duns Number: 752103403

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Gems VitBase - 09348265007008 Catalog Number :

Device Description : The Gems VitBase is intended for culture of embryos (up to 10 minutes) during em

Device Class : 2

Duns Number: 752103403

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

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