Data / Medical devices / System, Assisted Reproduction Laser
System, Assisted Reproduction Laser (MRX): 5 FDA-registered makers in 5 countries
5 establishments in 5 countries are registered with the FDA to make System, Assisted Reproduction Laser (product code MRX, Class 2, 21 CFR 884.6200). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on June 17, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MRX
- Device class
- 2
- Regulation
- 884.6200
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 1 |
| China | 1 |
| United Kingdom | 1 |
| Germany | 1 |
| Denmark | 1 |
Makers of System, Assisted Reproduction Laser
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| HAMILTON THORNE, Inc. | Beverly, MA, United States | Manufacturer | 3 | July 2, 2021 | 0 | 0 | 0 | api.fda.gov |
| Hua Yue Medical Technology Co., Ltd. | Guangzhou Guangdong, China | Manufacturer | 1 | June 17, 2026 | 0 | 0 | 0 | api.fda.gov |
| Research Instruments Ltd | Falmouth Cornwall, United Kingdom | Manufacturer | 1 | February 18, 2015 | 0 | 0 | 0 | api.fda.gov |
| Vitrolife GmbH | Landshut Bavaria, Germany | Manufacturer | 1 | March 25, 2020 | 0 | 0 | 0 | api.fda.gov |
| Vitrolife A/S | Viby J Midtjylland, Denmark | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.