Fertipro NV

Address:INDUSTRIE PARK NOORD 32,BEERNEM West-Vlaanderen,BE

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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) (8) General Purpose Reagent (PPM) (1) Stains, Chemical Solution (LED) (1)

Premarket Exempt

No Yes

Clear

VitalScreen Reagent 2 - 05411967001774 Catalog Number :

Device Description : VitalScreen is an in vitro diagnostic kit for the semi-quantitative determinatio VitalScreen is an in vitro diagnostic kit for the semi-quantitative determination of human sperm vitality by dye exclusion.The kit consist of 20ml of 1% Eosin Y in saline (product code: VITAL_1 and 30ml of 5% Nigrosin in saline (product code: VITAL_2).The eosin-nigrosin staining technique is based on the principle that dead cells will take up the eosin and as a result stain red. The nigrosin provides a dark background which makes it easier to assess the slides. The VitalScreen™ is based on the test procedure described in the WHO laboratory manual (2010).VitalScreen™ has a 24 month shelf life from date of produce. Reference is made to the product page of VitalScreen on the FertiPro website: www.fertipro.com

Device Class : 1

Duns Number: 373904101

Premarket Exempt : Yes

Product Code : LED

Prescription Use : No

Device Count : 1

HOS Test - 05411967001873 Catalog Number :

Device Description : Sperm vitality testThe hypo-osmotic swelling test is a sperm vitality test based Sperm vitality testThe hypo-osmotic swelling test is a sperm vitality test based on the principle that live spermatozoa swell due to the absorption of a hypo-osmotic solution. The HOS test is based on the test procedure described in the WHO laboratory manual for the examination of human semen and sperm-cervical mucus interaction.For more information, visit the FertiPro website: www.fertipro.com

Device Class : 1

Duns Number: 373904101

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

SpermFreeze - 05411967002009 Catalog Number :

Device Description : SpermFreeze (SPF) (20 ml) SpermFreeze is a medium for the cryopreservation of h SpermFreeze (SPF) (20 ml) SpermFreeze is a medium for the cryopreservation of human spermatozoa.SpermFreeze has a shelf life of 18 months.For the most recent information about the product specifications, instructions for use and MSDS, reference is made to the FertiPro website (www.fertipro.com)

Device Class :

Duns Number: 373904101

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

SpermFreeze - 05411967002016 Catalog Number :

Device Description : SpermFreezeSpermFreeze is a medium for the cryopreservation of human spermatozo SpermFreezeSpermFreeze is a medium for the cryopreservation of human spermatozoa.SpermFreeze has a shelf life of 18 months.For the most recent information about the product specifications, instructions for use and MSDS, reference is made to the FertiPro website (www.fertipro.com)

Device Class :

Duns Number: 373904101

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

SpermFreeze SSP - 05411967002023 Catalog Number :

Device Description : SpermFreeze SSPSpermFreeze SSP is a medium for freezing human sperm. SpermFreez SpermFreeze SSPSpermFreeze SSP is a medium for freezing human sperm. SpermFreeze has a shelf life of 18 months.For the most recent information about the product specifications, instructions for use and MSDS, reference is made to the FertiPro website (www.fertipro.com)

Device Class : 2

Duns Number: 373904101

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

VitriFreeze - 05411967002030 Catalog Number :

Device Description : VitriFreeze™ Freezing 1 (REF: VF1001) (1 ml) Component of VitriFreeze™ kit, whi VitriFreeze™ Freezing 1 (REF: VF1001) (1 ml) Component of VitriFreeze™ kit, which are a set of cell culture media designed for the vitrification of morula and blastocyst stage human embryos.For more information, see DI Number of VitriFreeze kit: 05411967001415The medium has a 12 month shelf life.For the latest version of the instructions for use or MSDS, visit the product page on our website (www.fertipro.com).

Device Class : 2

Duns Number: 373904101

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

VitriFreeze - 05411967002047 Catalog Number :

Device Description : VitriFreeze™ Freezing 2 (REF: VF2001) (1 ml) Component of VitriFreeze™ kit, whi VitriFreeze™ Freezing 2 (REF: VF2001) (1 ml) Component of VitriFreeze™ kit, which are a set of cell culture media designed for the vitrification of morula and blastocyst stage human embryos.For more information, see DI Number of VitriFreeze kit: 05411967001415The medium has a 12 month shelf life.For the latest version of the instructions for use or MSDS, visit the product page on our website (www.fertipro.com).

Device Class : 2

Duns Number: 373904101

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

VitriFreeze - 05411967002054 Catalog Number :

Device Description : VitriFreeze™ Pre-incubation medium (REF: VPI005) (5 ml) Component of VitriFreez VitriFreeze™ Pre-incubation medium (REF: VPI005) (5 ml) Component of VitriFreeze™ kit, which are a set of cell culture media designed for the vitrification of morula and blastocyst stage human embryos.For more information, see DI Number of VitriFreeze kit: 05411967001415The medium has a 12 month shelf life.For the latest version of the instructions for use or MSDS, visit the product page on our website (www.fertipro.com).

Device Class : 2

Duns Number: 373904101

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

VitriThaw - 05411967002108 Catalog Number :

Device Description : VitriThaw™ Thawing 1 (REF: VT1005) (5 ml) Component of VitriThaw™ kit, which ar VitriThaw™ Thawing 1 (REF: VT1005) (5 ml) Component of VitriThaw™ kit, which are a set of cell culture media designed for the thawing of vitrified morula and blastocyst stage human embryos (with VitriFreeze™ kit) .For more information, see DI Number of VitriThaw kit: 05411967001439. The medium has a 12 month shelf life.For the latest version of the instructions for use or MSDS, visit the product page on our website (www.fertipro.com).

Device Class : 2

Duns Number: 373904101

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

VitriThaw - 05411967002115 Catalog Number :

Device Description : VitriThaw™ Thawing 2 (REF: VT2001) (1 ml) Component of VitriThaw™ kit, which ar VitriThaw™ Thawing 2 (REF: VT2001) (1 ml) Component of VitriThaw™ kit, which are a set of cell culture media designed for the thawing of vitrified morula and blastocyst stage human embryos (with VitriFreeze™ kit) .For more information, see DI Number of VitriThaw kit: 05411967001439. The medium has a 12 month shelf life.For the latest version of the instructions for use or MSDS, visit the product page on our website (www.fertipro.com).

Device Class : 2

Duns Number: 373904101

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

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