Address:Jens Juuls Vej 20,Viby J Midtjylland,DK
Device Description : The EmbryoSlide+ ic8 dish is a single use, sterile accessory specially designed The EmbryoSlide+ ic8 dish is a single use, sterile accessory specially designed for embryo culture, handling and preparation for transfer.The EmbryoSlide+ ic8 dish has 8 culture wells, each to be used for storing a single embryo in individual culture in a microwell inside the well, providing a capacity of 8 embryos. Each well holds 20µL medium. In addition, four rinsing wells are available and can optionally be used if applicable in the specific clinic workflow. Each rinsing well holds 25-30µL medium. The culture area of the dish comprising both culture wells and rinsing wells must be covered with 1.6mL culture oil overlay which will reduce osmolarity changes during culture in a dry environment.The EmbryoSlide+ ic8 dish is equipped with barcode label area for unique identification of the culture dish, and a small area which can be used for manual writing. The EmbryoSlide+ ic8 dish has a sterility assurance level of 10-6 and is subject to Mouse Embryo Assay (MEA) and endotoxin testing before lot release.The EmbryoSlide+ ic8 dish is intended for culturing, handling and preparation for transfer of human embryos. The EmbryoSlide+ ic8 dish must be used together with the EmbryoScope+ incubator.
Device Class :
Duns Number: 308547608
Premarket Exempt : No
Prescription Use : Yes
Device Description : The EmbryoScope time-lapse incubator (Version D) provides an environment with co The EmbryoScope time-lapse incubator (Version D) provides an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. Device use is limited to five days (120 hr) covering the time from post-fertilization to day 5 of development.
Device Class : 2
Duns Number: 308547608
Premarket Exempt : No
Prescription Use : Yes
Device Description : EmbryoScope+ consists of the following devices with the following indications fo EmbryoScope+ consists of the following devices with the following indications for use:The EmbryoScope+ incubator provides an environment with controlled temperature and gas concentrations (CO2 and O2) for the development of embryos at or near body temperature. Use of the EmbryoScope+ incubator is limited to five days (120 hr) covering the time from post insemination to day five of development.The EmbryoSlide+ culture dish is intended for preparing, storing, and transferring human embryos. The EmbryoSlide+ culture dish must be used together with the EmbryoScope+ incubator.The EmbryoViewer software is intended for displaying, comparing, storing, and transferring images generated by theEmbryoScope+ incubator. This software includes a user annotation function for capturing information on embryo development parameters as well as a user-defined modeling function, which allows the user to combine annotatedinformation on embryo development parameters to aid in embryo selection. The EmbryoViewer software does not controlany hardware components in the EmbryoScope+ incubator.The ES Server software is intended to store, archive and transfer data. In addition, this software includes functions for managing models and performing calculations based on image data and embryo development parameters.The EmbryoScope+ incubator, EmbryoViewer software, and ES Server software must be used together to export embryo images from the EmbryoScope+ incubator. The EmbryoViewer software and ES Server software must be used together to analyze the embryo images.
Device Class : 1
Duns Number: 308547608
Premarket Exempt : No
Prescription Use : Yes
Device Description : The EmbryoSlide culture dish is intended for preparing, storing, and transferrin The EmbryoSlide culture dish is intended for preparing, storing, and transferring human embryos. It is intended to be used only with the EmbryoScope device.The EmbryoSlide culture dish contains two types of wells: wells, which are only used for rinsing and handling the embryos before or after incubation and wells in which the embryos reside during incubation. The EmbryoSlide culture dish fits exactly on the culture dish holder in the EmbryoScope time-lapse incubator and holds a maximum of 12 embryos in separate microwells. The EmbryoSlide culture dish contains a large oil reservoir with 12 wells for the incubation of 12 individual embryos and 4 special wells, two at each end of the culture dish that are intended for rinsing and general handling of the embryos either before or after incubation.. Each well has a volume of 25 μl. Inside each well there is a central depression where the embryo rests. The well has a diameter of approximately 250 μm.
Device Class :
Duns Number: 308547608
Premarket Exempt : No
Prescription Use : Yes
Device Description : The EmbryoSlide+ culture dish is a radiation-sterilized polystyrene culture dish The EmbryoSlide+ culture dish is a radiation-sterilized polystyrene culture dish containing two separate reservoirs. Each reservoir has eight culture wells, and each well is used to culture one embryo. Therefore, a total of 16 embryos can be cultured on one dish. Each dish includes four special wells that are only used for rinsing and handling the embryos either before or after incubation. An adhesive barcode label printed from the EmbryoViewer software is used to mark each dish. The barcode label contains two different 2D data matrices that provide information on the patient (name, patient ID, treatment ID, and insemination time). The EmbryoSlide+ culture dish has a sterility assurance level of 10-6 and a shelf-life of four years. This device is subject to mouse embryo assay (MEA) and endotoxin testing before lot release.
Device Class :
Duns Number: 308547608
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Micro Well Group Culture Dish is designed for efficient embryo handling and The Micro Well Group Culture Dish is designed for efficient embryo handling and culture. The nine (9) microwells are intended for embryo culture at all stages. The wells are intended to hold one embryo each. The area surrounding the wells can contain a sufficient amount of culture medium for all embryos, thereby allowing efficient culture setup and handling. The individual microwells allows individual evaluation of each embryo during group culture.The Micro Well Group Culture Dish is constructed of polysterene and is non-pyrogenic. The raw material has passed mouse embryo testing prior to production and the dish is sterilised by beta irradiation. Sterility Assurance level 10-6 (SAL 10-6).Indications for Use / Intended Use:For in vitro fertilisation, handling and embryo culture. It may be used for culturing of embryos using drop culture.
Device Class :
Duns Number: 308547608
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Micro Well Group Culture Dish is designed for efficient embryo handling and The Micro Well Group Culture Dish is designed for efficient embryo handling and culture. The sixteen (16) microwells are intended for embryo culture at all stages. The wells are intended to hold one embryo each. The area surrounding the wells can contain a sufficient amount of culture medium for all embryos, thereby allowing efficient culture setup and handling. The individual microwells allows individual evaluation of each embryo during group culture.The Micro Well Group Culture Dish is constructed of polysterene and is non-pyrogenic. The raw material has passed mouse embryo testing prior to production and the dish is sterilised by beta irradiation. Sterility Assurance level 10-6 (SAL 10-6).Indications for Use / Intended Use:For in vitro fertilisation, handling and embryo culture. It may be used for culturing of embryos using drop culture.
Device Class :
Duns Number: 308547608
Premarket Exempt : No
Prescription Use : Yes
Device Description : The KIDScore D3 tool provides decision support for prediction of likelihood of e The KIDScore D3 tool provides decision support for prediction of likelihood of embryos developing to the blastocyststage by scoring them according to their statistical viability.Adjunctive information provided by KIDScore D3 aids in the selection of embryo(s) for either transfer on Day 3, freezingor continued embryo development when, following morphological assessment on Day 3, there are multiple embryosdeemed suitable for transfer or freezing.The KIDScore D3 tool is only to be used with the EmbryoScope and EmbryoScope+ timelapse incubator systems.
Device Class : 2
Duns Number: 308547608
Premarket Exempt : No
Prescription Use : Yes