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Data / Medical devices / Catheter, Assisted Reproduction

Catheter, Assisted Reproduction (MQF): 18 FDA-registered makers in 9 countries

18 establishments in 9 countries are registered with the FDA to make Catheter, Assisted Reproduction (product code MQF, Class 2, 21 CFR 884.6110). 16 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 53 510(k) clearances under this code, the latest on February 12, 2026, and lists 6 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
MQF
Device class
2
Regulation
884.6110
Medical specialty
Obstetrics/Gynecology

Makers by country

CountryMakers
United States6
China3
Japan2
France2
India1
Belgium1
Costa Rica1
United Kingdom1
Sweden1

Makers of Catheter, Assisted Reproduction

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
Cook IncorporatedSpencer, IN, United StatesManufacturer10May 17, 2019000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer9May 17, 2019020api.fda.gov
Coopersurgical, Inc.Trumbull, CT, United StatesManufacturer, Specification developer6December 19, 2003000api.fda.gov
Medgyn Products, Inc.Westmont, IL, United StatesManufacturer6November 23, 2015000api.fda.gov
Kitazato CorporationFuji Shizuoka, JapanExporter to the US, Manufacturer5May 1, 2020000api.fda.gov
Kitazato CorporationMinato-ku Tokyo, JapanExporter to the US, Manufacturer5May 1, 2020000api.fda.gov
Allwin Medical Devices, Inc.Anaheim, CA, United StatesManufacturer2July 1, 2020000api.fda.gov
Allwin Medical Devices Pvt. Ltd.Surat Gujarat, IndiaManufacturer2July 1, 2020000api.fda.gov
Gynetics Medical Products NVLommel Limburg, BelgiumManufacturer2November 30, 2001000api.fda.gov
Cooper Medical, SRLLa Garita Alajuela, Costa RicaContract manufacturer, Manufacturer1December 13, 2002000api.fda.gov
Femasys Inc.Suwanee, GA, United StatesManufacturer1September 22, 2023000api.fda.gov
Guangzhou Hehong Biotech Co., Ltd.Guangzhou Guangdong, ChinaManufacturer1February 12, 2026000api.fda.gov
Laboratoire CCDPARIS Ile-de-France, FranceSpecification developer1May 27, 1999000api.fda.gov
Rocket Medical PlcWASHINGTON Sunderland, United KingdomManufacturer1February 28, 2000000api.fda.gov
Shenzhen VitaVitro Biotech Co.,Ltd.Shenzhen Guangdong, ChinaManufacturer1August 16, 2024000api.fda.gov
Vitrolife Sweden ABVastra Frolunda Vastra Gotaland, SwedenManufacturer1July 23, 2025000api.fda.gov
ProdimedNEUILLY-EN-THELLE Oise, FranceContract manufacturer0000api.fda.gov
Uks Medical Technology (chongqing) Co., Ltd.Chongging Sichuan, ChinaContract manufacturer0000api.fda.gov

Updated February 12, 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.