Coda
The Coda Air Purification System will be used as an accessory item during assisted reproductive procedures
4manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Research Instruments Ltd, United Kingdom |
|---|---|
| FDA product code | MQG |
| Device type | Accessory, Assisted Reproduction |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6120 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-09-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K59549 Coda Inline Filter for G185 US | 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 |
| Thermo Scientific | Thermo Electron LED GmbH | 2 |
| Multiroom IVF incubator | Esco Medical Technologies, UAB | 2 |
| Kryo 360 Freezer | Planer Limited | 2 |
Showing 12 of 41. All products under Accessory, Assisted Reproduction
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160504 | 2016-07-18 |
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.