Develops and manufactures IVF media, embryo incubators, vitrifiers, and sterile consumables for reproductive medicine.
Genea Biomedx Pty Ltd
Sydney · Valencia · Madrid · Hongkong · SuzhouNew on Amplifa
About Genea Biomedx
Genea Biomedx is a medical technology company founded in 2012 with clinical origins in Sydney IVF (now Genea), which has been developing IVF culture media since the 1990s. The product portfolio includes the sequential media range Gems®, the Benchtop Embryo Incubator Geri® with continuous embryo monitoring, the Vitrification System Gavi®, electronic Witnessing Systems (Guardian, Gidget®), Cryo Storage Systems (Gelida 47, Gelida 800), the Genie solution for preimplantation genetic diagnostics, and the AI-assisted sperm analyzer Glimmer. IVF media with Human Serum Albumin and antibiotics, embryo incubators, vitrifiers, and sterile consumables are manufactured in an ISO 13485 certified facility in Sydney. The products carry CE marking and FDA approval; the company serves over 600 customers in more than 26 countries through direct sales and a global distributor network. Locations include Sydney, Valencia, Madrid, Hong Kong, and Suzhou.
- Site
- Sydney NSW 2000, Australia
- Processes
- Manufacturing of IVF media (nutrient media, sequential media, buffers, vitrification solutions), Manufacturing of Embryo Incubators, Manufacturing of Vitrifiers (embryo vitrifiers), Manufacturing of sterile consumables for IVF, Genetic analysis of embryo biopsies (PGT-A, PGT-SR, PGT-M), Flow cytometry (cell, microorganism, and fluid analysis), Automated Sperm Analysis (Semen Analysis), Electronic Sample Tracking (Electronic Witnessing with RFID and QR codes)
- Materials
- IVF media with antibiotics and human serum albumin, Human-Serum-Albumin (10 mg/ml or 5 mg/ml Supplement), Gentamicin (0.01 mg/ml Supplement), Cryoprotectants: Ethylene glycol (EG), DMSO, Trehalose, Coated Silicon Dioxide (Sperm Wash Gradient Set), IVF Media with Human Serum Albumin (5 or 10 mg/ml), Human-Serum-Albumin, Gentamicin (0.01 mg/ml)
- Certificates
- ISO 13485:2016 & EN ISO 13485:2016, ISO 13485:2016 (MDSAP), ISO 13485:2016 / EN ISO 13485:2016
- Founded
- 2012
- Industries
- IVF / Reproductive Medicine, Fertility Clinics, Biotechnology, Medical Technology, Genomics/Diagnostics
- 01
Research & Development (media, devices, software)
- 02
Regulatory Certification (CE, FDA, TGA, NMPA)
- 03
Manufacture of IVF media in Sydney (ISO 13485)
- 04
Manufacturing of Embryo Incubators, Vitrifiers, and Sterile Consumables
- 05
Batch Quality Control (COA)
- 06
Distribution via Direct Sales and Distributors
- 07
End-to-End Support and Technical Customer Service
Media Formulations & Processes
IVF Media with Human Serum Albumin (5 or 10 mg/ml)
Sequential culture media for IVF/ICSI with albumin and gentamicin supplement.
Human-Serum-Albumin
Protein supplement in culture and sperm media.
Gentamicin (0.01 mg/ml)
Antibiotic supplement for contamination control in media.
Cryoprotectants (Ethylene glycol, DMSO, Trehalose)
Components of vitrification solutions for embryos.
Coated Silicon Dioxide (Sperm Wash Gradient Set)
Separation medium to separate highly motile sperm from sperm plasma.
Locations
Sydney
AUHead Office; Manufacturing of IVF Media, Incubators, Vitrifiers, and Sterile Consumables (ISO 13485)
- Materials
- IVF Media with Human Serum Albumin and Gentamicin; Cryoprotectants
- Manufacturing Facility for IVF Media (medically accredited, ISO 13485)
Valencia
ESEuropean Head Office & Showroom
Madrid
ESEuropean Workshop
Hongkong
CNAPAC Head Office (Reg No. 63648980)
Suzhou
CNChina Headquarters
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Manufacturing of IVF media (nutrient media, sequential media, buffers, vitrification solutions)Engineering | – | – | – | – | IVF media with antibiotics and human serum albumin, Cryoprotectants (ethylene glycol/DMSO/trehalose) |
| Manufacturing of Embryo IncubatorsEngineering | – | – | – | – | – |
| Manufacturing of Vitrifiers (embryo vitrifiers)Engineering | – | – | – | – | – |
| Manufacturing of sterile consumables for IVFEngineering | – | – | – | – | – |
| Genetic analysis of embryo biopsies (PGT-A, PGT-SR, PGT-M)Testing | – | – | – | – | – |
| Flow cytometry (cell, microorganism, and fluid analysis)Testing | – | – | – | – | – |
| Automated Sperm Analysis (Semen Analysis)Testing | – | – | – | – | – |
| Electronic Sample Tracking (Electronic Witnessing with RFID and QR codes)Testing | – | – | – | – | – |
| Cryopreservation / Cryo Storage in liquid nitrogen (ultra-low temperatures)Testing | – | – | – | – | – |
8 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Benchtop Embryo Incubator with Time-lapse (continuous embryo monitoring, chamber with microscope) | Genea Biomedx Geri | – | – | – | – |
| Electronic Witnessing System (RFID/QR) | Genea Biomedx Guardian | – | – | – | – |
| Witnessing and ART Workflow Management System | Genea Biomedx Gidget | – | – | – | – |
| Flow Cytometer | Genea Biomedx Glimmer Flow | – | – | – | – |
| Automated Sperm Analyzer (AI-based) | Genea Biomedx Glimmer Semen Analyser | – | – | – | – |
| Liquid Nitrogen Cryo Storage Tank with Remote Temperature Monitoring and Alarm | Genea Biomedx Gelida 47 | – | – | – | – |
| Cryo Storage System with automated LN2 refilling, dual verification, and ultra-low temperature | Genea Biomedx Gelida 800 | – | – | – | – |
| Vitrification System (Gavi Medium Cartridge) | Genea Biomedx Gavi | – | – | – | – |
Additional services
Reference customers
Quality & Approvals
Manufacturing in Sydney is certified according to ISO 13485:2016 (BSI, Certificate MD 630526) and also includes MDSAP registration (BSI, MDSAP 685522). Certificates of Analysis (COA) are issued for every charge; the products meet CE, FDA, NMPA, and TGA requirements.
| Evidence | Sydney |
|---|---|
| ISO 13485:2016 / EN ISO 13485:2016 | |
| ISO 13485:2016 (MDSAP) |
History
- 1990
Sydney IVF (now Genea) develops the first proprietary culture medium (M91)
- 1997
First generation media in clinical application at Sydney IVF
- 1998
Media formulation licensed to Cook Medical
- 2006
Second generation media in clinical application
- 2008
Second generation licensed to Cook Medical
- 2009
Third Generation: Gems®
- 2011
Clinical trials begin in Genea ART Clinics
- 2012
Founding of Genea Biomedx
- 2013
Gems® in full clinical application in Genea ART Clinics
- 2015
Tom Beckitt joins the company; ISO-13485 initial registration
- 2016
Gems® with CE marking, EU and Canada
- 2017
FDA approval for the majority of Gems® media
- 2018
MDSAP registration