Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012853704

FEI Number

3012853704

Entity Name

GENEA BIOMEDX Pty Ltd.

City/State/Country

Sydney New South Wales, AU

Establishment Address

level2, 321 Kent Street, Sydney New South Wales 2000, AU

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Genea Biomedx (Owner Number: 10052443)

Owner / Operator Contact Address

level2, 321 Kent Street, Sydney, AU-NSW 2000, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K180188

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2017-05-15
MQG	Accessory, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6120	2017-11-19
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2017-10-19
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2017-06-14
MQG	Accessory, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6120	2018-06-12

Official Correspondent

Regulatory Biomedx

US Agent Details

Stephen Lieberman Email: lieberman@donawa.com Phone: (561) 3020777

Related Public Records

Same Entity

Genea Biomedx

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K011481	Conception Technologies	10% PVP; 10% PVP IN EBSS SOLUTION	2001-07-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2020	CooperSurgical, Inc.	2	Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated to be flush fitted within workstations. Intended use: Provide a favorable temperature environment for the embryo during the IVF procedure.

Similar Registrations

Registration Number	Establishment Name	Location
2031824	Vitrolife Inc.	San Diego, CA, US
3014295858	COOPER MEDICAL, SRL	La Garita Alajuela, CR
3014755376	CooperSurgical Distribution B.V.	Herten Limburg, NL
3036725842	GYNOTEC B.V.	Malden Gelderland, NL
3004048494	ORIGIO A/S	Ballerup Hovedstaden, DK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012853704. Last updated year: 2026. Please use registration number 3012853704 when referencing this establishment in official correspondence.