Geri Embryo Incubator

The Geri Embryo Incubator is a benchtop incubator with six modular incubation chambers each with its own temperature control capability and separate gas inlet feed. Each chamber contains…

Registry build 21.09.26

The Geri Embryo Incubator is a benchtop incubator with six modular incubation chambers each with its own temperature control capability and separate gas inlet feed. Each chamber contains heating elements in its lid and base, together with an orange light source (591 nm) and camera with integrated optics that take time-lapse images of embryos and allows operators to view embryos without removing them from the incubation chamber. Inside each chamber is a filter used to filter the gas mixture entering the incubation chamber from the gas supply. The gas is supplied from standard premixed medical gas cylinders. The Geri Embryo Incubator includes firmware to control the incubator settings, and software to control patient information and settings.

10manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (8), Hubei (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code MQK
Manufacturer City Province Registered as Device types
Shenzhen Boomingshing Medical Device Co., Ltd. Shenzhen Guangdong Contract manufacturer 5
Shenzhen JPY ION-Tech. Co., Ltd. Shenzhen Guangdong Contract manufacturer 20
Dongguan King Medical Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 14
Wuhan Huchuang Union Technology Co., Ltd. Wuhan Hubei Manufacturer 8
Shenzhen VitaVitro Biotech Co., Ltd. Shenzhen Guangdong Manufacturer 7
HUA YUE Medical Technology Co., Ltd. Guangzhou Guangdong Manufacturer 7
CGN Gray (Shenzhen) Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 5
Gimbo Medical Technology Shenzhen Co., Ltd. Shenzhen Guangdong Manufacturer 3
Guangzhou Hehong Biotech Co., Ltd. Guangzhou Guangdong Manufacturer 2
Shandong Wego Ruisheng Medical Device Co., Ltd. Weihai Shandong Manufacturer 2

Record

Regulatory record for Geri Embryo Incubator
Listed by Genea Biomedx Pty Ltd., Australia
FDA product code MQK
Device type Labware, Assisted Reproduction
Device class Class 2
Regulation 21 CFR 884.6160
Establishment Specification developer, Manufacturer
510(k) K171736
Record published 2017-12-08
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Geri Embryo Incubator
Catalogue number Size Status
GERI-INS-01 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cryotec Reprolife Inc. 20
VitriGuard Origio A/S 16
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ZyMot DxNow Inc. 10
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cryo-GO Vitrification Device Fujifilm Irvine Scientific 9
LifeGlobal® GPS® Dishware Coopersurgical, Inc. 7
LifeGlobal® GPS® Dishware LifeGlobal Group, LLC 7
Nest VT Cook Incorporated 5
Surestrip Allwin Medical Devices, Inc. 5
Minvitro Vitrification Straw Guangzhou Hehong Biotech Co., Ltd. 5
Rapid-i Kit Vitrolife Sweden AB 5

Showing 12 of 102. All products under Labware, Assisted Reproduction

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer