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Data / Medical devices / Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use (JQC): 112 FDA-registered makers in 17 countries

112 establishments in 17 countries are registered with the FDA to make Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use (product code JQC, Class 1, 21 CFR 862.2050). 4 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 38 510(k) clearances under this code, the latest on May 30, 2019, and lists 14 recall events (0 Class I). FDA data exported November 3, 2026.

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

Makers by country

CountryMakers
United States36
China35
India11
Germany9
Mexico3
Switzerland3
South Korea2
Taiwan2
Denmark2
Japan2
Spain1
Malaysia1
Slovenia1
Vietnam1
Turkey1
United Kingdom1
Latvia1

Makers of Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

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
EmCyte CorporationFort Myers, FL, United StatesManufacturer, Specification developer3May 30, 2019000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer3December 6, 2010000api.fda.gov
Arteriocyte Medical Systems, Inc.Hopkinton, MA, United StatesManufacturer, Repackager or relabeler, Specification developer1August 12, 2002000api.fda.gov
Global Life Sciences Solutions USA LLCMarlborough, MA, United StatesComplaint file establishment, Specification developer1September 16, 1981000api.fda.gov
Accumax Lab Devices Pvt LtdGandhi nagar Gujarat, IndiaManufacturer0000api.fda.gov
Accuster Technologies Pvt. Ltd.New Delhi, IndiaSpecification developer0000api.fda.gov
Advanced Engineering, Inc.Huntington, IN, United StatesContract manufacturer0000api.fda.gov
Advanced Molding TechnologiesCircle Pines, MN, United StatesContract manufacturer0000api.fda.gov
Aikang Medtech Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Andreas Hettich GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Anji Spenq Industrial Co., Ltd.Huzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Apex BiologixW Bountiful, UT, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Apothecaries Sundries MFG Pvt LtdGURUGRAM Haryana, IndiaManufacturer0000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer0000api.fda.gov
Arthrex Logistic CenterFort Myers, FL, United StatesContract manufacturer, Contract sterilizer, Manufacturer0000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
B.T.I. Biotechnology Institute, S.L.Miñano Alava, SpainManufacturer0000api.fda.gov
Babson DiagnosticsAustin, TX, United StatesManufacturer, Specification developer0000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesSpecification developer0020api.fda.gov
Beckman Coulter, Inc.Miami, FL, United StatesContract manufacturer0000api.fda.gov
Beckman Coulter, Inc.Indianapolis, IN, United StatesSpecification developer0000api.fda.gov
Beijing Hanbaihan Medical Devices Co., Ltd.Beijing City, ChinaManufacturer0000api.fda.gov
Biobase Biodustry(shandong)co., LtdJinan Shandong, ChinaManufacturer0000api.fda.gov
Biomed Plastics Co.Taicang, Jiangsu, ChinaManufacturer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer0010api.fda.gov
BSL Co., Ltd.Busan, South KoreaManufacturer0000api.fda.gov
Beckman Coulter, IncIndianapolis, IN, United StatesContract manufacturer0010api.fda.gov
CG Bio Co., Ltd.Hwaseong-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Changsha Yingtai Instrument Co., Ltdchangsha city Hunan, ChinaExporter to the US, Manufacturer0000api.fda.gov
Charter Medical, LLCWinston Salem, NC, United StatesContract 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
CogmedixWest Boylston, MA, United StatesContract manufacturer0000api.fda.gov
CalibreScientific US, Inc.Vancouver, WA, United StatesManufacturer0000api.fda.gov
Diatrust Medical Co., Ltd.Nanjing City Jiangsu, ChinaManufacturer0000api.fda.gov
Digisystem Laboratory Instruments Inc.New Taipei City, TaiwanManufacturer0000api.fda.gov
Dlab Scientific Malaysia SDN.BHDSenai Johor, MalaysiaExporter to the US, Manufacturer0000api.fda.gov
DLAB Scientific Co., Ltd.Shunyi District Beijing, ChinaExporter to the US, Manufacturer0000api.fda.gov
Domel, d.o.o., (Business Unit LABS)Zelezniki, SloveniaManufacturer0000api.fda.gov
Dongguan Q & S Electronic Manufacturing Company LimitedDongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Drucker Diagnostics, LLCPhilipsburg, PA, United StatesComplaint file establishment, Manufacturer, Remanufacturer0000api.fda.gov
Endonest Medical Systems LLPPALGHAR Maharashtra, IndiaManufacturer0000api.fda.gov
Eppendorf SeHamburg, GermanyManufacturer0000api.fda.gov
Eppendorf Manufacturing CorporationEnfield, CT, United StatesContract manufacturer0000api.fda.gov
Eppendorf Zentrifugen GmbHLeipzig Saxony, GermanyContract manufacturer0000api.fda.gov
Fenwal, Inc.Lake Zurich, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Fresenius Kabi WarrendaleWarrendale, PA, United StatesManufacturer0000api.fda.gov
Gemmy Industrial Corp.Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Greens Surgicals Private LimitedVadodara Gujarat, IndiaManufacturer0000api.fda.gov
Guangzhou Jet Bio-Filtration Co., LtdGuangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Guangzhou Four E's Scientific Co., Ltd.GUANGZHOU Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Hangzhou Rollmed Co.,ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
HBH Biotechnology LimitedYantai Shandong, ChinaExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Heathrow Scientific, LLCVernon Hills, IL, United StatesSpecification developer0000api.fda.gov
Hermle Labortechnik GMBHWehingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Hospital Equipment MFG. Co.NOIDA Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Hunan Xiang Yi Laboratory Instrument Development Co., LtdChangsha Hunan, ChinaManufacturer0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Infitek Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Integra Biotechnical, SA de CVTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Jiangsu Kangjian Medical Apparatus Co., Ltd.JIANGYAN Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Kit CompanyPhoenix, AZ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Lab Fish Equipment (zhejiang) Co,,ltdHuzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Labpeak Co.,ltdJinan Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
LW Scientific, Inc.Lawrenceville, GA, United StatesManufacturer, Remanufacturer, Repackager or relabeler0010api.fda.gov
Mark EnterprisesNashik Maharashtra, IndiaManufacturer0000api.fda.gov
Marken Healthtech LimitedNASHIK Maharashtra, IndiaManufacturer0000api.fda.gov
MEDTOX Diagnostics, Inc.Pleasanton, CA, United StatesManufacturer0000api.fda.gov
Mida Precision Mold CorporationMy Yen Commune Tay Ninh, VietnamManufacturer0000api.fda.gov
Novem Medical S. De R.L. De C.V.TIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
Nuo Therapeutics, Inc.Houston, TX, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Nuve Sanayi Malzemeleri Imalat Ve Ticaret A.S.Ankara, TurkeyManufacturer0000api.fda.gov
Orthoascent LLCWestminster, CO, United StatesComplaint file establishment, Specification developer0000api.fda.gov
P Bhogilal Pvt LtdKolkata West Bengal, IndiaManufacturer0000api.fda.gov
Pall NewquayNewquay Cornwall, United KingdomManufacturer0000api.fda.gov
Paul E. Danchell A/SJyderup Sjaelland, DenmarkContract manufacturer0000api.fda.gov
Pfau Medizinische Instrumente GMBHWANFRIED Hesse, GermanyContract manufacturer0000api.fda.gov
Pro-Tech Design & MFG., Inc.Santa Fe Springs, CA, United StatesContract manufacturer0000api.fda.gov
Pall International, SarlFribourg, SwitzerlandExporter to the US, Specification developer0000api.fda.gov
ReapplixBirkerod Sjaelland, DenmarkSpecification developer0000api.fda.gov
REGEN LAB SaLE MONT-SUR-LAUSANNE Vaud, SwitzerlandManufacturer0000api.fda.gov
Rudolf Storz GMBHEMMINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
RWD Life Science Co., Ltd.Shenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Remi Elektrotechnik Ltd.Dist. Palghar Maharashtra, IndiaManufacturer0000api.fda.gov
Sarstedt AG & Co. KGNUMBRECHT North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Sarstedt, Inc.Newton, NC, United StatesManufacturer0000api.fda.gov
Scitek Global Co.,ltdJinan Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Lu Xiangyi Centrifuge Instrument Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shanghai Youding International Trade Co., Ltd.Shanghai, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Sia ElmiRiga, Latvia, LatviaManufacturer0000api.fda.gov
Sichuan Shuke Instrument Co.,ltdChengdu Sichuan, ChinaExporter to the US, Manufacturer0000api.fda.gov
Sigma Laborzentrifugen GMBHOSTERODE Lower Saxony, GermanyManufacturer0000api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesManufacturer, Specification developer0000api.fda.gov
Syntr Health Technologies, Inc.Irvine, CA, United StatesManufacturer0000api.fda.gov
Sysmex Corporation Techno ParkKOBE Hyogo, JapanSpecification developer0000api.fda.gov
Shanghai Gene Era Bio-Science Co., Ltd.Fengxian Shanghai, ChinaContract manufacturer, Manufacturer0000api.fda.gov
SpineSmith Holdings, LLCAustin, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Sysmex RA Co., LTD, Main OfficeShiojiri Nagano, JapanManufacturer0000api.fda.gov
Tecan Schweiz AGMAENNEDORF ZUERICH Zurich, SwitzerlandSpecification developer0000api.fda.gov
THERMO ELECTRON LED GmbHOSTERODE Lower Saxony, GermanyManufacturer, Specification developer0000api.fda.gov
Tiger Medical GroupShanghai, ChinaExporter to the US, Specification developer0000api.fda.gov
Thermo Fisher Scientific (Suzhou) Instruments Co., LtdSuzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
Wuxi Nest Biotechnology Co., LtdWuxi Jiangsu, ChinaManufacturer0000api.fda.gov
Yantai Addcare Bio-Tech Co., Ltd.Yantai Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhejiang Huawei Scientific Instrument Co LtdLinHai Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Lidesen Medical Instrument Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhejiang Saining Biotechnology Co.,ltdTaizhou Zhejiang, ChinaManufacturer0000api.fda.gov
Zhuhai Longtime Biological Technology Co., Ltd.Zhuhai City Guangdong, ChinaManufacturer0000api.fda.gov
Zien Medical Technologies LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Zenith Lab (Jiangsu) Co.,LTDChangzhou Jiangsu, ChinaManufacturer0000api.fda.gov

Updated May 30, 2019. 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.