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. Products Specialized Consumables for Assist Reproduction

Specialized Consumables for Assisted Reproduction (Medical Device)

Registration Certificate No.: GDMDR 20232181838

In vitro fertilization (IVF) refers to the process of taking sperm and eggs out of the body and fertilizing egg with sperm in vitro in an artificially controlled environment. JET BIOFIL specialized consumables for assisted reproduction are designed to provide safe and reliable products for complex IVF and other assisted reproductive applications. These consumables undergo rigorous third-party testing, including biocompatibility, in vitro mouse embryo, and human sperm survival tests to ensure that human germ cells and embryos remain viable throughout the process of preparation, storage, operation, culture, and transfer in an in vitro environment.


Model: Center-well Culture Dish, 35/60/90mm Culture Dish (Flat Bottom), Four-well Culture Plate


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Thawing frozen embryos to restore their biological activity; in vitro culture of embryos
Egg collection, washing, and digestion of granular cells outside the egg
Droplet culture of embryos
Egg collection, washing, and digestion of granular cells outside the egg; embryo freezing/thawing
Freezing and recovery of embryos and in vitro culture of embryos

Material

* Polystyrene (PS)

* Conforming to USP Class VI standards


Features
* Selecting medical-grade polystyrene as the preferred raw material for its highly transparent surface that facilitates the observation of eggs and embryos
* Smooth and thin bottom design for efficient heat transfer and constant temperature and pH
* Designed lid to facilitate aseptic operation and maintain a stable environment for embryo culture over long periods
* Gear ring design on the dish side for easy hold and use to effectively reduce the risk of contamination
* Surface without TC treatment for optimum consistency of media droplets
* Conducting rigorous third-party testing to ensure non-embryotoxic, non-pyrogenic, non-cytotoxic, non-genotoxic, or non-mutagenic
* Implementing strict production and quality testing controls as per ISO 13485 and relevant GMP requirements to ensure stable and reliable product quality
* Sterilized by irradiation, SAL 10-6

Ordering information

Cat. No. Model Description Surface Type Sterlie
Qty.Per
Bag(Box)
Qty./Case
IVF050060 Center-well IVF-Specialized Center-well Culture Dish Non-treated Y 10 600
IVF050035 35mm, Flat bottom IVF-Specialized 35 mm Culture Dish Non-treated Y 10 960
IVF051060 60mm, Flat bottom IVF-Specialized 60 mm Culture Dish Non-treated Y 10 600
IVF050090 90mm, Flat bottom IVF-Specialized 90 mm Culture Dish Non-treated Y 10 500
IVF041004 Four-well plate IVF-Specialized Four-well Culture Plate Non-treated Y 1 100

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