Skip to the page

Data / Medical devices / Unit, Filter, Membrane

Unit, Filter, Membrane (JRL): 38 FDA-registered makers in 9 countries

38 establishments in 9 countries are registered with the FDA to make Unit, Filter, Membrane (product code JRL, Class 1, 21 CFR 862.2050). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on August 5, 1982, and lists 0 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.

Product code
JRL
Device class
1
Regulation
862.2050
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
China18
United States10
Germany2
United Kingdom2
Mexico2
Taiwan1
France1
Netherlands1
Ireland1

Makers of Unit, Filter, Membrane

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
Aeon Biotherapeutics Corp.New Taipei City, TaiwanManufacturer0000api.fda.gov
Apothicom DistributionParis Ile-de-France, FranceManufacturer0000api.fda.gov
AquamedixEden Prairie, MN, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Aprios Custom Mfg.Minneapolis, MN, United StatesContract manufacturer0000api.fda.gov
Changzhou Meiguan Care Products Technology Co.,ltd.Changzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
CITOTEST Labware Manufacturing CO., LTD.Haimen Jiangsu, ChinaManufacturer0000api.fda.gov
Citotest Scientific Co.,ltd.Nanjing Jiangsu, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Cnsac Medshop GMBHTheilheim Bavaria, GermanyManufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer0000api.fda.gov
Diatrust Medical Co., Ltd.Nanjing City Jiangsu, ChinaManufacturer0000api.fda.gov
E.A.M Benelux B.VALMERE Flevoland, NetherlandsManufacturer0000api.fda.gov
Evereast Medical Products Group Co., LtdChangyuan City Henan, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
EmCyte CorporationFort Myers, FL, United StatesSpecification developer0000api.fda.gov
Flexicare Medical (dongguan) Ltd.DONGGUAN CITY Guangdong, ChinaContract manufacturer0000api.fda.gov
Flexicare Medical Ltd.RHONDDA CYNON TAFF Wales, United KingdomSpecification developer0000api.fda.gov
Guangzhou Huiming Fibre Products Co., Ltd.Guangzhou Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Guangzhou Jet Bio-Filtration Co., LtdGuangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Hurricane MedicalBradenton, FL, United StatesManufacturer0000api.fda.gov
Infitek Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
IVEMSA S.A. de C.V DIVISION AG INDUSTRIESTijuana Baja California, MexicoManufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Jiangsu Jumao X-Care Medical Equipment Co., LtdDanyang Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jiangsu Power Electromechanical Technology Co.,ltdDanyang Jiangsu, ChinaManufacturer0000api.fda.gov
Medite Medical GMBHBurgdorf Lower Saxony, GermanyManufacturer0000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer0000api.fda.gov
Medease Life Co.,LtdDANYANG Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Merck Millipore Ltd.COUNTY CORK Munster, IrelandManufacturer0000api.fda.gov
Ningbo Alps Medical Technology Co., LtdNingbo Zhejiang, ChinaManufacturer0000api.fda.gov
Reprocessing Products Corporation (RPC)Tucson, AZ, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Shandong Jinlai Huanhai Medical Technology Co.,ltdYantai Shandong, ChinaManufacturer0000api.fda.gov
Shenzhen Bi-Rich Medical Devices Co., LtdShenzhen City Guangdong, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Shenzhen Homed Medical Device Co LtdShenzhen city Guangdong, ChinaSpecification developer0000api.fda.gov
Shenzhen Homed Medical Device Co LtdDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Yimi Care Technology Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
SUNSET HEALTHCARE SOLUTIONS, Inc.Chicago, IL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Sunset Healthcare Solutions Central WarehouseElgin, IL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Vacsax LimitedPlymouth Devon, United KingdomManufacturer0000api.fda.gov

Updated August 5, 1982. 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.