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Data / Medical devices / Accessory, Assisted Reproduction, Exempt

Accessory, Assisted Reproduction, Exempt (PUB): 19 FDA-registered makers in 10 countries

19 establishments in 10 countries are registered with the FDA to make Accessory, Assisted Reproduction, Exempt (product code PUB, Class 2, 21 CFR 884.6120). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on January 14, 2020, 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
PUB
Device class
2
Regulation
884.6120
Medical specialty
Obstetrics/Gynecology

Makers by country

CountryMakers
United States5
China3
Japan2
Lithuania2
United Kingdom2
France1
Indonesia1
Germany1
Brazil1
Australia1

Makers of Accessory, Assisted Reproduction, Exempt

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 StatesManufacturer1January 14, 2020010api.fda.gov
ASTEC CO., Ltd.Kasuya Fukuoka, JapanComplaint file establishment, Manufacturer0000api.fda.gov
Cryo Bio SystemSaint Ouen sur Iton Orne, FranceManufacturer0000api.fda.gov
Esco Medical Technologies, UABRamuciai Kauno Apskritis, LithuaniaManufacturer0000api.fda.gov
Hua Yue Medical Technology Co., Ltd.Guangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Lifeaire SystemsShoemakersville, PA, United StatesManufacturer, Specification developer0000api.fda.gov
Mve Biological Solutions Us LLCNew Prague, MN, United StatesManufacturer0000api.fda.gov
MVE Cryogenic Biological Equipment (Chengdu) Co., LtdPidu District Chengdu Sichuan, ChinaManufacturer0000api.fda.gov
Phasetwo, A Division Of Tomco2 Systems CompanyAlpharetta, GA, United StatesManufacturer0000api.fda.gov
PHC CorporationOra-gun Gunma, JapanManufacturer0000api.fda.gov
PLANER LimitedSUNBURY, MIDDLESEX England, United KingdomManufacturer0000api.fda.gov
PT PHC IndonesiaCikarang Barat Bekasi Jawa Barat, IndonesiaContract manufacturer0000api.fda.gov
Research Instruments LtdFalmouth Cornwall, United KingdomContract manufacturer0000api.fda.gov
THERMO ELECTRON LED GmbHLangenselbold Hesse, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
TMRW LIFE SCIENCES, Inc.New York, NY, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
UAB Life InstrumentsSkaidiskes Vilniaus Apskritis, LithuaniaContract manufacturer0000api.fda.gov
Watanabe Equipamentos MedicosCravinhos, Sao Paulo, BrazilManufacturer0000api.fda.gov
William A. Cook Australia Pty, Ltd.EIGHT MILE PLAINS Queensland, AustraliaSpecification developer0000api.fda.gov
Wuhan Huchuang Union Technology Co., Ltd.Wuhan Hubei, ChinaManufacturer0000api.fda.gov

Updated January 14, 2020. 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.