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…
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.
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.
| 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
| 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
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GERI-INS-01 | In distribution |
Same Product Code
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|---|---|---|
| Cryotec | Reprolife Inc. | 20 |
| VitriGuard | Origio A/S | 16 |
| G-Vitri™ Vitrification Straw | Gimbo Medical Technology Shenzhen Co., Ltd. | 15 |
| ZyMot | DxNow Inc. | 10 |
| LensHooke Sperm Separation Device | Bonraybio Co., Ltd. | 9 |
| 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.