Data / Medical devices / Mixer, Blood Tube

Mixer, Blood Tube (GLE): 17 FDA-registered makers in 9 countries

Name: FDA-registered makers of Mixer, Blood Tube
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

17 establishments in 9 countries are registered with the FDA to make Mixer, Blood Tube (product code GLE, 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 5 510(k) clearances under this code, the latest on November 22, 1982, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: GLE
Device class: 1
Regulation: 862.2050
Medical specialty: Clinical Chemistry

Makers by country

Country	Makers
China	6
Taiwan	2
United States	2
Japan	2
India	1
Sweden	1
France	1
Germany	1
South Korea	1

Makers of Mixer, Blood Tube

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
Anji Spenq Industrial Co., Ltd.	Huzhou Zhejiang, China	Exporter to the US, Manufacturer	api.fda.gov
Apothecaries Sundries MFG Pvt Ltd	GURUGRAM Haryana, India	Manufacturer, Repackager or relabeler	api.fda.gov
Cytodelics AB	Sodertalje Stockholm, Sweden	Manufacturer	api.fda.gov
Digisystem Laboratory Instruments Inc.	New Taipei City, Taiwan	Manufacturer	api.fda.gov
Gemmy Industrial Corp.	Taipei City, Taiwan	Exporter to the US, Manufacturer	api.fda.gov
Guangzhou Four E's Scientific Co., Ltd.	GUANGZHOU Guangdong, China	Contract manufacturer	api.fda.gov
Hangzhou Rollmed Co.,ltd.	Hangzhou Zhejiang, China	Contract manufacturer, Manufacturer	api.fda.gov
Huzhou Junda Industry Co., Ltd.	Anji Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Process For PRF Sarl	Nice Alpes-Maritimes, France	Specification developer	api.fda.gov
Sarstedt AG & Co. KG	NUMBRECHT North Rhine-Westphalia, Germany	Manufacturer	api.fda.gov
Sarstedt, Inc.	Newton, NC, United States	Manufacturer	api.fda.gov
Sysmex Corporation Techno Park	KOBE Hyogo, Japan	Specification developer	api.fda.gov
SYSMEX CORPORATION i-SQUARE	Kakogawa Hyogo, Japan	Manufacturer	api.fda.gov
Sysmex America, Inc. - Vernon Hills	Vernon Hills, IL, United States	Manufacturer	api.fda.gov
Ycellbio Medical Co., Ltd.	Seoul, South Korea	Manufacturer	api.fda.gov
Zhejiang Lidesen Medical Instrument Co., Ltd	Hangzhou Zhejiang, China	Exporter to the US, Manufacturer	api.fda.gov
Zhuhai Longtime Biological Technology Co., Ltd.	Zhuhai City Guangdong, China	Manufacturer	api.fda.gov

Updated November 22, 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.