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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

CountryMakers
United States8
Sweden3
China3
Denmark2
Germany2
Japan1
Belgium1
Australia1
Canada1
Costa Rica1
Poland1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Coopersurgical, Inc.Trumbull, CT, United StatesComplaint file establishment, Manufacturer, Specification developer55July 17, 2020070api.fda.gov
Origio A/SBallerup Hovedstaden, DenmarkSpecification developer44July 17, 2020000api.fda.gov
Vitrolife Sweden ABVastra Frolunda Vastra Gotaland, SwedenManufacturer20August 7, 2024000api.fda.gov
Irvine Scientific LLCSanta Ana, CA, United StatesComplaint file establishment, Specification developer19September 12, 2025000api.fda.gov
LifeGlobal Group, LLCTrumbull, CT, United StatesSpecification developer12February 17, 2015000api.fda.gov
Invitrocare IncFrederick, MD, United StatesManufacturer, Repackager or relabeler11March 23, 2006000api.fda.gov
Kitazato CorporationFuji Shizuoka, JapanComplaint file establishment, Exporter to the US, Manufacturer10August 26, 2025000api.fda.gov
Nidacon International ABMOLNDAL Vastra Gotaland, SwedenManufacturer, Specification developer9June 15, 2010000api.fda.gov
VITROMED GmbHLangenfeld (Rheinland) North Rhine-Westphalia, GermanyComplaint file establishment, Manufacturer7March 21, 2025000api.fda.gov
AMS Denmark ApSHundested Hovedstaden, DenmarkManufacturer, Repackager or relabeler, Specification developer5December 18, 2024000api.fda.gov
Fertipro N.V.BEERNEM West-Vlaanderen, BelgiumContract manufacturer, Manufacturer5May 30, 2025000api.fda.gov
Gimbo Medical Technology Shenzhen Co., Ltd.Shenzhen Guangdong, ChinaManufacturer5January 8, 2025000api.fda.gov
Vitrolife Inc.San Diego, CA, United StatesManufacturer5March 20, 2003000api.fda.gov
Gynemed GMBH & Co. KGSierksdorf Schleswig-Holstein, GermanyManufacturer4November 19, 2020000api.fda.gov
Shenzhen VitaVitro Biotech Co.,Ltd.Shenzhen Guangdong, ChinaManufacturer4February 1, 2022000api.fda.gov
GENEA BIOMEDX Pty Ltd.Sydney New South Wales, AustraliaManufacturer3September 28, 2017000api.fda.gov
Casebioscience, Inc.Guelph Ontario, CanadaManufacturer2February 20, 2026000api.fda.gov
Reprolife America, LLCKingwood, TX, United StatesManufacturer1August 27, 2024000api.fda.gov
Shandong Wego Ruisheng Medical Device Co.,ltdWeihai Shandong, ChinaExporter to the US, Manufacturer1July 1, 2024000api.fda.gov
Apotek Produktion & Laboratorier ABUmea Vasterbotten, SwedenContract manufacturer0000api.fda.gov
Cooper Medical, SRLLa Garita Alajuela, Costa RicaContract manufacturer0000api.fda.gov
FUJIFILM Biosciences INC.Santa Ana, CA, United StatesContract manufacturer0030api.fda.gov
Nolato Stargard Sp. z o.o.Stargard Zachodniopomorskie, PolandContract manufacturer, Contract sterilizer0000api.fda.gov
Vitrolife Inc.Englewood, CO, United StatesContract manufacturer, Manufacturer for export0000api.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.