Address:FLOJELBERGSGATAN 16B,MOLNDAL Vastra Gotaland,SE
Device Description : The product is intended to be used for solution for re-suspending sperm after d The product is intended to be used for solution for re-suspending sperm after density gradient preparation, for use in intra-uterine insemination, one of the techniques for ART (assisted reproductive technology).
Device Class : 2
Duns Number: 631825841
Premarket Exempt : No
Prescription Use : Yes
Device Description : SpermCatch is a medium designed to modulate sperm motility in a physiological ma SpermCatch is a medium designed to modulate sperm motility in a physiological manner, to facilitate injecting a single spermatozoa into an oocyte (ICSI).ICSI is an available procedure in Assisted Reproduction Technology (ART).
Device Class : 2
Duns Number: 631825841
Premarket Exempt : No
Prescription Use : Yes
Device Description : The product is intended to be used as a cryopreservative for protecting human sp The product is intended to be used as a cryopreservative for protecting human sperm during cryopreservation, an adjunct to one of the techniques for ART (assisted reproductive technology).
Device Class : 2
Duns Number: 631825841
Premarket Exempt : No
Prescription Use : Yes
Device Description : The product is intended for use as an oil overlay during gamete and embryo cultu The product is intended for use as an oil overlay during gamete and embryo culture for ART, (Assisted Reproduction Technology) and during manipulationsoutside the incubator
Device Class : 2
Duns Number: 631825841
Premarket Exempt : No
Prescription Use : Yes
Device Description : The product is intended for use as an oil overlay during gamete and embryo cultu The product is intended for use as an oil overlay during gamete and embryo culture for ART, (Assisted Reproduction Technology) and during manipulationsoutside the incubator.
Device Class : 2
Duns Number: 631825841
Premarket Exempt : No
Prescription Use : Yes
Device Description : An optimized staining technique for assessment of sperm vitality. For use with An optimized staining technique for assessment of sperm vitality. For use with Assisted Reproduction Technology (ART)
Device Class : 1
Duns Number: 631825841
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The product is intended to be used for the separation and purification of sperma The product is intended to be used for the separation and purification of spermatozoa by density gradient centrifugation of human semen samples,where the prepared sperm are used for the treatment of involuntary infertility by utilizing one of the Assisted Reproductive Technologies (ART).
Device Class : 2
Duns Number: 631825841
Premarket Exempt : No
Prescription Use : Yes
Device Description : VitriBlast is intended for ultra-rapid freezing of human blastocysts. This kit i VitriBlast is intended for ultra-rapid freezing of human blastocysts. This kit is designed for use with Nidacon's ThermoBlast Thaw Kit for optimal recovery of specimens. This product is used for Assisted Reproductive Technology (ART.) procedures.
Device Class : 2
Duns Number: 631825841
Premarket Exempt : No
Prescription Use : Yes
Device Description : Nidacon's ThermoBlast Thaw Kit for intended to be used with Nidacon’s VitriBlast Nidacon's ThermoBlast Thaw Kit for intended to be used with Nidacon’s VitriBlast for optimal recovery of specimens is This product is used for Assisted Reproductive Technology (ART.) procedures.
Device Class : 2
Duns Number: 631825841
Premarket Exempt : No
Prescription Use : Yes
Device Description : The product is intended to be used for the separation and purification of sperma The product is intended to be used for the separation and purification of spermatozoa by density gradient centrifugation of human semen samples,where the prepared sperm are used for the treatment of involuntary infertility by utilizing one of the Assisted Reproductive Technologies (ART).
Device Class : 2
Duns Number: 631825841
Premarket Exempt : No
Prescription Use : Yes