Data / Medical devices / Australia / GENEA BIOMEDX Pty Ltd.
GENEA BIOMEDX Pty Ltd.: FDA-registered device maker in Sydney New South Wales, Australia, 6 510(k) clearances
GENEA BIOMEDX Pty Ltd. is registered with the FDA (registration 3012853704) in Sydney New South Wales, Australia. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 7, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012853704
- Address
- level2, 321 Kent Street, Sydney New South Wales, Australia, 2000
- Owner or operator
- Genea Biomedx (10052443)
- Roles
- Manufacturer, Specification developer
- First device listed
- May 15, 2017
- Registered through
- 2026
- Brand names listed
- Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems Geri Medium, and Gems VitBase, Gems Vitrification Set and Gems Warming Set, Genea Biomedx Gems Oocyte Retrieval Buffer ORB-20, ORB-50, Geri Embryo Incubator and Geri Dish, Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Assisted Reproduction | MQG | 2 | Specification developer | accessdata.fda.gov |
| Labware, Assisted Reproduction | MQK | 2 | Specification developer | accessdata.fda.gov |
| Media, Reproductive | MQL | 2 | Manufacturer | accessdata.fda.gov |
| Microscope And Microscope Accessories, Reproduction, Assisted | MTX | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 7, 2018 | K180188 | Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish | MQG | Substantially Equivalent | Genea Biomedx Pty, Ltd. | accessdata.fda.gov |
| April 20, 2018 | K180304 | Geri Embryo Incubator and Geri Dish | MQG | Substantially Equivalent | Genea Biomedx Pty, Ltd. | accessdata.fda.gov |
| November 15, 2017 | K171736 | Geri Embryo Incubator and Geri Dish | MQG | Substantially Equivalent | Genea Biomedx Pty, Ltd. | accessdata.fda.gov |
| September 28, 2017 | K170498 | Gems Oocyte Retrieval Buffer ORB-20, ORB-50 | MQL | Substantially Equivalent | Genea Biomedx Pty, Ltd. | accessdata.fda.gov |
| May 24, 2017 | K162409 | Gems Vitrification Set, Gems Warming Set | MQL | Substantially Equivalent | Genea Biomedx Pty, Ltd. | accessdata.fda.gov |
| May 12, 2017 | K161261 | Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase | MQL | Substantially Equivalent | Genea Biomedx Pty, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Media, Reproductive
- All makers of Accessory, Assisted Reproduction
- All makers of Labware, Assisted Reproduction
- All makers of Microscope And Microscope Accessories, Reproduction, Assisted
Updated June 7, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.