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Data / Medical devices / Block, Heating

Block, Heating (JRG): 19 FDA-registered makers in 9 countries

19 establishments in 9 countries are registered with the FDA to make Block, Heating (product code JRG, 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 3 510(k) clearances under this code, the latest on February 18, 1983, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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

Makers by country

CountryMakers
China6
United States4
Belgium2
South Korea2
India1
Austria1
Australia1
Canada1
Finland1

Makers of Block, Heating

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, IndiaManufacturer0000api.fda.gov
Baxter SALESSINES Hainaut, BelgiumManufacturer0000api.fda.gov
Biegler GMBHMAUERBACH Niederosterreich, AustriaContract manufacturer0000api.fda.gov
Biobase Biodustry(shandong)co., LtdJinan Shandong, ChinaManufacturer0000api.fda.gov
Baxter R&D Europe SRLBraine-l'Alleud Wallonia, BelgiumSpecification developer0000api.fda.gov
Crosstex InternationalRush, NY, United StatesContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
Hunan Xiang Yi Laboratory Instrument Development Co., LtdChangsha Hunan, ChinaManufacturer0000api.fda.gov
Hangzhou Bioer Technology Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jinan Babio Biotechnology Co.,ltd.Jinan City Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Lab Fish Equipment (zhejiang) Co,,ltdHuzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Leica Biosystems Melbourne Pty LtdMELBOURNE Victoria, AustraliaManufacturer0000api.fda.gov
Leica Biosystems Richmond, Inc.Richmond, IL, United StatesManufacturer0000api.fda.gov
Nanoentek IncHwaseong Gyeonggi, South KoreaManufacturer0000api.fda.gov
Nanoentek IncSeoul, South KoreaSpecification developer0000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Athens, OH, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Scican Ltd.TORONTO Ontario, CanadaSpecification developer0000api.fda.gov
ScigeneSanta Clara, CA, United StatesManufacturer0000api.fda.gov
Wallac OYTURKU Varsinais-Suomi, FinlandComplaint file establishment, Manufacturer0000api.fda.gov
Zhejiang Gene Science Co., Ltdshaoxing Zhejiang, ChinaManufacturer0000api.fda.gov

Updated February 18, 1983. 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.