The EmbryoScope time-lapse incubator (Version D) provides an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated…
The EmbryoScope time-lapse incubator (Version D) provides an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. Device use is limited to five days (120 hr) covering the time from post-fertilization to day 5 of development.
Who Else Makes It
Concentrated in Guangdong (2), Hubei (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for EmbryoScope time-lapse incubator | Listed by | Vitrolife A/S, Denmark |
| FDA product code | MQG |
| Device type | Accessory, Assisted Reproduction |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6120 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Record published | 2016-08-26 |
| Record revised | 2026-04-27 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 50 °C; Handling environment temperature 20 to 30 °C; Storage environment atmospheric pressure 80 to 106 KiloPascal; Special storage condition: Keep dry; Handling environment humidity 0 to 80 % RH; Storage environment humidity 30 to 80 % RH |
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.