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Data / Medical devices / Freezer

Freezer (JRM): 21 FDA-registered makers in 7 countries

21 establishments in 7 countries are registered with the FDA to make Freezer (product code JRM, Class 1, 21 CFR 862.2050). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on June 9, 1992, 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
JRM
Device class
1
Regulation
862.2050
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States10
China4
India3
Luxembourg1
France1
Denmark1
Turkey1

Makers of Freezer

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
Accuster Technologies Pvt. Ltd.New Delhi, IndiaSpecification developer0000api.fda.gov
B Medical Systems SARLHosingen Luxembourg, LuxembourgManufacturer0000api.fda.gov
Biobase Biodustry(shandong)co., LtdJinan Shandong, ChinaManufacturer0000api.fda.gov
C Change Surgical LLCWinston Salem, NC, United StatesManufacturer, Specification developer0000api.fda.gov
Cryo Bio SystemSaint Ouen sur Iton Orne, FranceManufacturer0000api.fda.gov
Currie Medical, Inc.Franklin, TN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Currie Medical, Inc.Norfolk, VA, United StatesManufacturer, Remanufacturer, Specification developer0000api.fda.gov
Elcold Frysere. Hobro ApSHobro Nordjylland, DenmarkManufacturer0000api.fda.gov
Global Cooling, Inc.Athens, OH, United StatesManufacturer0010api.fda.gov
HELMER Inc.Noblesville, IN, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Jiangsu Rooe Medical Technology Co., Ltd.Zhangjiagang City Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Kari MedicalWest Orange, NJ, United StatesSpecification developer0000api.fda.gov
Midea Biomedical Co., LtdHefei Anhui, ChinaManufacturer0000api.fda.gov
Nuve Sanayi Malzemeleri Imalat Ve Ticaret A.S.Ankara, TurkeyManufacturer0000api.fda.gov
P Bhogilal Pvt LtdKolkata West Bengal, IndiaManufacturer0000api.fda.gov
Qingdao Haier Biomedical Co., LtdQingdao Shandong, ChinaManufacturer0000api.fda.gov
Rac Medical SolutionsBruceton, TN, United StatesManufacturer0000api.fda.gov
Remi Elektrotechnik Ltd.Dist. Palghar Maharashtra, IndiaManufacturer0000api.fda.gov
So-Low Environmental Equip. Co.,Inc.Cincinnati, OH, United StatesManufacturer0000api.fda.gov
Thermo Fisher Scientific (asheville) LLCMarietta, OH, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Thermo Fisher Scientific (asheville) LLCAsheville, NC, United StatesComplaint file establishment, Manufacturer0000api.fda.gov

Updated June 9, 1992. 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.