FDA Registration
Active
🇦🇺 Australia
GENEA BIOMEDX Pty Ltd.
Reg #: 3012853704
·
FEI: 3012853704
·
Expires 2026
Products
4
Proprietary Names
5
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- GENEA BIOMEDX Pty Ltd.
- Registration Number
- 3012853704
- FEI Number
- 3012853704
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- level2, 321 Kent Street
- City
- Sydney New South Wales
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K161261
Owner / Operator
- Firm Name
- Genea Biomedx
- Operator Number
- 10052443
- Address
- level2, 321 Kent Street
- City
- Sydney
- State
- New South Wales
- Postal Code
- 2000
- Country
- AU
- Correspondent
- Regulatory Biomedx
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Media, Reproductive | MQL | Class 2 | Obstetrics/Gynecology | No | 2017-05-15 |
| Accessory, Assisted Reproduction | MQG | Class 2 | Obstetrics/Gynecology | No | 2017-11-19 |
| Labware, Assisted Reproduction | MQK | Class 2 | Obstetrics/Gynecology | No | 2018-04-23 |
| Microscope And Microscope Accessories, Reproduction, Assisted | MTX | Class 1 | Obstetrics/Gynecology | No | 2018-04-23 |
Proprietary Names
Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems Geri Medium, and Gems VitBase
Geri Embryo Incubator and Geri Dish
Genea Biomedx Gems Oocyte Retrieval Buffer ORB-20, ORB-50
Gems Vitrification Set and Gems Warming Set
Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility