Hemocytometer (GHO): 21 FDA-registered makers in 8 countries

Name: FDA-registered makers of Hemocytometer
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

21 establishments in 8 countries are registered with the FDA to make Hemocytometer (product code GHO, Class 1, 21 CFR 864.6160). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on May 20, 1987, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: GHO
Device class: 1
Regulation: 864.6160
Medical specialty: Hematology

Makers by country

Country	Makers
China	6
United States	3
India	3
South Korea	3
Netherlands	2
Taiwan	2
Germany	1
Israel	1

Makers of Hemocytometer

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.

Maker	Location	Role	Source
Attain Technologies BV	Heerhugowaard Noord-Holland, Netherlands	Manufacturer	api.fda.gov
Bioanalytic GMBH	Umkirch/Freiburg Baden-Wurttemberg, Germany	Manufacturer	api.fda.gov
Bonraybio Co., Ltd.	Taichung, Taiwan	Manufacturer	api.fda.gov
Diatrust Medical Co., Ltd.	Nanjing City Jiangsu, China	Manufacturer	api.fda.gov
Digisystem Laboratory Instruments Inc.	New Taipei City, Taiwan	Manufacturer	api.fda.gov
Guangzhou Four E's Scientific Co., Ltd.	GUANGZHOU Guangdong, China	Specification developer	api.fda.gov
Hausser Scientific Co., Inc.	Horsham, PA, United States	Manufacturer	api.fda.gov
Hospital Equipment MFG. Co.	NOIDA Uttar Pradesh, India	Contract manufacturer, Manufacturer, Repackager or relabeler	api.fda.gov
Heuer International (A division of GST Corporation Limited)	NOIDA Uttar Pradesh, India	Foreign private label distributor, Manufacturer, Repackager or relabeler	api.fda.gov
Incyto Co., Ltd.	Cheonan-si Chungnam, South Korea	Manufacturer	api.fda.gov
Infitek Co., Ltd.	Shanghai, China	Manufacturer	api.fda.gov
Kashmir Surgical Works	AMBALA Haryana, India	Exporter to the US, Manufacturer	api.fda.gov
Labpeak Co.,ltd	Jinan Shandong, China	Exporter to the US, Manufacturer	api.fda.gov
Leja Products B.V.	NIEUW VENNEP Noord-Holland, Netherlands	Manufacturer	api.fda.gov
Nanoentek Inc	Hwaseong Gyeonggi, South Korea	Manufacturer	api.fda.gov
Nanoentek Inc	Seoul, South Korea	Specification developer	api.fda.gov
Scitek Global Co.,ltd	Jinan Shandong, China	Exporter to the US, Manufacturer	api.fda.gov
Sefi Medical Instruments	Haifa, Israel	Manufacturer	api.fda.gov
STS Corporation	Duluth, GA, United States	Complaint file establishment, Repackager or relabeler, Specification developer	api.fda.gov
Vitrolife Inc.	San Diego, CA, United States	Manufacturer	api.fda.gov
Zhejiang Saining Biotechnology Co.,ltd	Taizhou Zhejiang, China	Manufacturer	api.fda.gov

Updated May 20, 1987. 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.