Thermo Scientific
2 catalogue numbers from Heracell 240i, listed by Thermo Electron LED GmbH, Germany, under Accessory, Assisted Reproduction. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
2catalogue numbers in this listing
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.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Saint-Gobain Life Sciences (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 5 |
| Wuhan Huchuang Union Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 8 |
| HUA YUE Medical Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 7 |
| CGN Gray (Shenzhen) Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
Record
| Listed by | Thermo Electron LED GmbH, Germany |
|---|---|
| FDA product code | MQG |
| Device type | Accessory, Assisted Reproduction |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6120 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K023465 |
| Record published | 2016-09-23 |
| 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 |
|---|---|---|
| Heracell 240i | In distribution | |
| Heracell 150i | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Coda® | LifeGlobal Group, LLC | 42 |
| Thermo Scientific Forma | Thermo Fisher Scientific (Asheville) LLC | 22 |
| Rocket | Rocket Medical PLC | 6 |
| Kryo ART Freezer | Planer Limited | 6 |
| Panasonic | PHC Corporation | 6 |
| Cook | William A. Cook Australia PTY, Ltd. | 5 |
| Metiec | Wuhan Huchuang Union Technology Co., Ltd. | 3 |
| BT37 Incubator | Planer Limited | 3 |
| RI Witness | Research Instruments Ltd | 3 |
| Multiroom IVF incubator | Esco Medical Technologies, UAB | 2 |
| Kryo 360 Freezer | Planer Limited | 2 |
| PHCbi | PHC Corporation | 2 |
Showing 12 of 41. All products under Accessory, 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.