Data / Medical devices / Media, Reproductive
Media, Reproductive (MQL): 24 FDA-registered makers in 11 countries
24 establishments in 11 countries are registered with the FDA to make Media, Reproductive (product code MQL, Class 2, 21 CFR 884.6180). 19 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 260 510(k) clearances under this code, the latest on August 28, 2026, and lists 11 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MQL
- Device class
- 2
- Regulation
- 884.6180
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Sweden | 3 |
| China | 3 |
| Denmark | 2 |
| Germany | 2 |
| Japan | 1 |
| Belgium | 1 |
| Australia | 1 |
| Canada | 1 |
| Costa Rica | 1 |
| Poland | 1 |
Makers of Media, Reproductive
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 |
|---|---|---|---|---|---|---|---|---|
| Coopersurgical, Inc. | Trumbull, CT, United States | Complaint file establishment, Manufacturer, Specification developer | 55 | July 17, 2020 | 0 | 7 | 0 | api.fda.gov |
| Origio A/S | Ballerup Hovedstaden, Denmark | Specification developer | 44 | July 17, 2020 | 0 | 0 | 0 | api.fda.gov |
| Vitrolife Sweden AB | Vastra Frolunda Vastra Gotaland, Sweden | Manufacturer | 20 | August 7, 2024 | 0 | 0 | 0 | api.fda.gov |
| Irvine Scientific LLC | Santa Ana, CA, United States | Complaint file establishment, Specification developer | 19 | September 12, 2025 | 0 | 0 | 0 | api.fda.gov |
| LifeGlobal Group, LLC | Trumbull, CT, United States | Specification developer | 12 | February 17, 2015 | 0 | 0 | 0 | api.fda.gov |
| Invitrocare Inc | Frederick, MD, United States | Manufacturer, Repackager or relabeler | 11 | March 23, 2006 | 0 | 0 | 0 | api.fda.gov |
| Kitazato Corporation | Fuji Shizuoka, Japan | Complaint file establishment, Exporter to the US, Manufacturer | 10 | August 26, 2025 | 0 | 0 | 0 | api.fda.gov |
| Nidacon International AB | MOLNDAL Vastra Gotaland, Sweden | Manufacturer, Specification developer | 9 | June 15, 2010 | 0 | 0 | 0 | api.fda.gov |
| VITROMED GmbH | Langenfeld (Rheinland) North Rhine-Westphalia, Germany | Complaint file establishment, Manufacturer | 7 | March 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| AMS Denmark ApS | Hundested Hovedstaden, Denmark | Manufacturer, Repackager or relabeler, Specification developer | 5 | December 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| Fertipro N.V. | BEERNEM West-Vlaanderen, Belgium | Contract manufacturer, Manufacturer | 5 | May 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Gimbo Medical Technology Shenzhen Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 5 | January 8, 2025 | 0 | 0 | 0 | api.fda.gov |
| Vitrolife Inc. | San Diego, CA, United States | Manufacturer | 5 | March 20, 2003 | 0 | 0 | 0 | api.fda.gov |
| Gynemed GMBH & Co. KG | Sierksdorf Schleswig-Holstein, Germany | Manufacturer | 4 | November 19, 2020 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen VitaVitro Biotech Co.,Ltd. | Shenzhen Guangdong, China | Manufacturer | 4 | February 1, 2022 | 0 | 0 | 0 | api.fda.gov |
| GENEA BIOMEDX Pty Ltd. | Sydney New South Wales, Australia | Manufacturer | 3 | September 28, 2017 | 0 | 0 | 0 | api.fda.gov |
| Casebioscience, Inc. | Guelph Ontario, Canada | Manufacturer | 2 | February 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| Reprolife America, LLC | Kingwood, TX, United States | Manufacturer | 1 | August 27, 2024 | 0 | 0 | 0 | api.fda.gov |
| Shandong Wego Ruisheng Medical Device Co.,ltd | Weihai Shandong, China | Exporter to the US, Manufacturer | 1 | July 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| Apotek Produktion & Laboratorier AB | Umea Vasterbotten, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cooper Medical, SRL | La Garita Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Biosciences INC. | Santa Ana, CA, United States | Contract manufacturer | 0 | 0 | 3 | 0 | api.fda.gov | |
| Nolato Stargard Sp. z o.o. | Stargard Zachodniopomorskie, Poland | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vitrolife Inc. | Englewood, CO, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 28, 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.