Skip to the page
Get started – free

Data / Medical devices / Needle, Assisted Reproduction

Needle, Assisted Reproduction (MQE): 18 FDA-registered makers in 11 countries

18 establishments in 11 countries are registered with the FDA to make Needle, Assisted Reproduction (product code MQE, Class 2, 21 CFR 884.6100). 14 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 33 510(k) clearances under this code, the latest on June 15, 2026, and lists 1 recall event (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
MQE
Device class
2
Regulation
884.6100
Medical specialty
Obstetrics/Gynecology

Makers by country

CountryMakers
United States5
Japan2
China2
France2
Australia1
United Kingdom1
Sweden1
India1
Belgium1
Costa Rica1
Germany1

Makers of Needle, 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
Coopersurgical, Inc.Trumbull, CT, United StatesSpecification developer4June 12, 2019000api.fda.gov
William A. Cook Australia Pty, Ltd.EIGHT MILE PLAINS Queensland, AustraliaComplaint file establishment, Manufacturer3January 12, 2018000api.fda.gov
Kitazato CorporationFuji Shizuoka, JapanExporter to the US, Manufacturer2July 11, 2017000api.fda.gov
Kitazato CorporationMinato-ku Tokyo, JapanExporter to the US, Manufacturer2July 11, 2017000api.fda.gov
Rocket Medical PlcWASHINGTON Sunderland, United KingdomManufacturer2August 8, 2003000api.fda.gov
Vitrolife Sweden ABVastra Frolunda Vastra Gotaland, SwedenManufacturer2November 21, 2017000api.fda.gov
Allwin Medical Devices, Inc.Anaheim, CA, United StatesManufacturer1November 25, 2019000api.fda.gov
Allwin Medical Devices Pvt. Ltd.Surat Gujarat, IndiaManufacturer1November 25, 2019000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer1January 21, 1999000api.fda.gov
Gimbo Medical Technology Shenzhen Co., Ltd.Shenzhen Guangdong, ChinaManufacturer1June 15, 2026000api.fda.gov
Gynetics Medical Products NVLommel Limburg, BelgiumManufacturer1November 9, 2001000api.fda.gov
Laboratoire CCDPARIS Ile-de-France, FranceSpecification developer1June 8, 1999000api.fda.gov
Medgyn Products, Inc.Westmont, IL, United StatesManufacturer1October 7, 2005000api.fda.gov
Shenzhen VitaVitro Biotech Co.,Ltd.Shenzhen Guangdong, ChinaManufacturer1November 15, 2024000api.fda.gov
CIVCO Medical Instruments Co., Inc.Coralville, IA, United StatesManufacturer, Specification developer0000api.fda.gov
Cooper Medical, SRLLa Garita Alajuela, Costa RicaContract manufacturer0000api.fda.gov
Eurofins STERIPAC GMBHCalw-Altburg Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
ProdimedNEUILLY-EN-THELLE Oise, FranceContract manufacturer0000api.fda.gov

Updated June 15, 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.