Fortuna

Fortuna In-Vitro Fertilization (IVF) Workstations

Registry build 21.09.26
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).

Chinese manufacturers registered for FDA product code PUB
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

Regulatory record for Fortuna
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

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 numbers for Fortuna
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

Other products under the same FDA 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer