Fortuna
Fortuna In-Vitro Fertilization (IVF) Workstations
3manufacturers in China registered for this device type
28catalogue numbers in this listing
Who Else Makes It
Concentrated in Hubei (1), Guangdong (1), Sichuan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuhan Huchuang Union Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 8 |
| HUA YUE Medical Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 7 |
| MVE Cryogenic Biological Equipment (Chengdu) Co., Ltd. | Pidu District Chengdu | Sichuan | Manufacturer | 3 |
Record
| Listed by | Research Instruments Ltd, United Kingdom |
|---|---|
| FDA product code | PUB |
| Device type | Accessory, Assisted Reproduction, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6120 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-09-19 |
| Record revised | 2024-09-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FORTUNA 1800RE IVF 240V SERIAL NUMBER | In distribution | |
| FORTUNA 900 LAF 3FT FORTUNA WORKSTATION | In distribution | |
| FORTUNA 1800 IVF | In distribution | |
| FORTUNA 1500LE IVF 120V SERIAL NUMBER | In distribution | |
| FORTUNA 1800MPE IVF 120V SERIAL NUMBER | In distribution | |
| FORTUNA 1500 IVF WS 5FT W/LEFT ELEC HEAT | In distribution | |
| FORTUNA 1800 DUAL HEAT WS 6FT W/DUAL ELEC HEAT | In distribution | |
| FORTUNA 1800RE IVF 120V SERIAL NUMBER | In distribution | |
| FORTUNA 900 IVF WS 3FT W/ELEC HEAT | In distribution | |
| FORTUNA 1500RE IVF 240V SERIAL NUMBER | In distribution | |
| FORTUNA 1200E IVF 240V SERIAL NUMBER | In distribution | |
| FORTUNA 1800DE IVF 120V SERIAL NUMBER | In distribution | |
| FORTUNA 1500 IVF WS 5FT W/RIGHT ELEC HEAT | In distribution | |
| FORTUNA 1500 LAF 5FT FORTUNA WORKSTATION | In distribution | |
| FORTUNA 1500LE IVF 240V SERIAL NUMBER | In distribution | |
| FORTUNA 900E IVF 240V SERIAL NUMBER | In distribution | |
| FORTUNA 1200 ICSI WS 4FT ANTIVIBRATION | In distribution | |
| FORTUNA 1800 MULTI ELEC WS 6FT ANTIVIBRATION | In distribution | |
| FORTUNA 1800DE IVF 240V SERIAL NUMBER | In distribution | |
| FORTUNA 1800LE IVF 240V SERIAL NUMBER | In distribution | |
| FORTUNA 1500RE IVF 120V SERIAL NUMBER | In distribution | |
| 1200 IVF Workstation | In distribution | |
| FORTUNA 1800MPE IVF 240V SERIAL NUMBER | In distribution | |
| FORTUNA 1800 LAF 6FT FORTUNA WORKSTATION | In distribution | |
| FORTUNA 1800LE IVF 120V SERIAL NUMBER | In distribution | |
| FORTUNA 900E IVF 120V SERIAL NUMBER | In distribution | |
| FORTUNA 1800 IVF WS 6FT W/RIGHT ELEC HEAT | In distribution | |
| Fortuna | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| K-Systems | Coopersurgical, Inc. | 66 |
| Mars | Research Instruments Ltd | 19 |
| Multi-zone ART Workstation | Esco Medical Technologies, UAB | 13 |
| CT37 Incubator | Planer Limited | 9 |
| Titan | Research Instruments Ltd | 7 |
| Multiroom IVF incubator | Esco Medical Technologies, UAB | 6 |
| K-Systems | Research Instruments Ltd | 6 |
| Hariomed | HUA YUE Medical Technology Co., Ltd. | 4 |
| G185 | Research Instruments Ltd | 4 |
| PHCbi | PHC Corporation | 3 |
| BT37 | Planer Limited | 2 |
| Aire~Lifeline | Lifeaire Systems | 2 |
Showing 12 of 27. All products under Accessory, Assisted Reproduction, Exempt
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.