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
| Country | Makers |
|---|---|
| United States | 36 |
| China | 35 |
| India | 11 |
| Germany | 9 |
| Mexico | 3 |
| Switzerland | 3 |
| South Korea | 2 |
| Taiwan | 2 |
| Denmark | 2 |
| Japan | 2 |
| Spain | 1 |
| Malaysia | 1 |
| Slovenia | 1 |
| Vietnam | 1 |
| Turkey | 1 |
| United Kingdom | 1 |
| Latvia | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| EmCyte Corporation | Fort Myers, FL, United States | Manufacturer, Specification developer | 3 | May 30, 2019 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer | 3 | December 6, 2010 | 0 | 0 | 0 | api.fda.gov |
| Arteriocyte Medical Systems, Inc. | Hopkinton, MA, United States | Manufacturer, Repackager or relabeler, Specification developer | 1 | August 12, 2002 | 0 | 0 | 0 | api.fda.gov |
| Global Life Sciences Solutions USA LLC | Marlborough, MA, United States | Complaint file establishment, Specification developer | 1 | September 16, 1981 | 0 | 0 | 0 | api.fda.gov |
| Accumax Lab Devices Pvt Ltd | Gandhi nagar Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Accuster Technologies Pvt. Ltd. | New Delhi, India | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Advanced Engineering, Inc. | Huntington, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Advanced Molding Technologies | Circle Pines, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aikang Medtech Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Andreas Hettich GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anji Spenq Industrial Co., Ltd. | Huzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apex Biologix | W Bountiful, UT, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apothecaries Sundries MFG Pvt Ltd | GURUGRAM Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex Logistic Center | Fort Myers, FL, United States | Contract manufacturer, Contract sterilizer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex Manufacturing Inc. | Pendleton, SC, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Ave Maria, FL, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B.T.I. Biotechnology Institute, S.L. | Miñano Alava, Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Babson Diagnostics | Austin, TX, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Miami, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Indianapolis, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Hanbaihan Medical Devices Co., Ltd. | Beijing City, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biobase Biodustry(shandong)co., Ltd | Jinan Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomed Plastics Co. | Taicang, Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| BSL Co., Ltd. | Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc | Indianapolis, IN, United States | Contract manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| CG Bio Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changsha Yingtai Instrument Co., Ltd | changsha city Hunan, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Charter Medical, LLC | Winston Salem, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CITOTEST Labware Manufacturing CO., LTD. | Haimen Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Citotest Scientific Co.,ltd. | Nanjing Jiangsu, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cogmedix | West Boylston, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CalibreScientific US, Inc. | Vancouver, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diatrust Medical Co., Ltd. | Nanjing City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digisystem Laboratory Instruments Inc. | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dlab Scientific Malaysia SDN.BHD | Senai Johor, Malaysia | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DLAB Scientific Co., Ltd. | Shunyi District Beijing, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Domel, d.o.o., (Business Unit LABS) | Zelezniki, Slovenia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Q & S Electronic Manufacturing Company Limited | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Drucker Diagnostics, LLC | Philipsburg, PA, United States | Complaint file establishment, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Endonest Medical Systems LLP | PALGHAR Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eppendorf Se | Hamburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eppendorf Manufacturing Corporation | Enfield, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eppendorf Zentrifugen GmbH | Leipzig Saxony, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fenwal, Inc. | Lake Zurich, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresenius Kabi Warrendale | Warrendale, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gemmy Industrial Corp. | Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greens Surgicals Private Limited | Vadodara Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Jet Bio-Filtration Co., Ltd | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Four E's Scientific Co., Ltd. | GUANGZHOU Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Rollmed Co.,ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HBH Biotechnology Limited | Yantai Shandong, China | Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heathrow Scientific, LLC | Vernon Hills, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hermle Labortechnik GMBH | Wehingen Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hospital Equipment MFG. Co. | NOIDA Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hunan Xiang Yi Laboratory Instrument Development Co., Ltd | Changsha Hunan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heuer International (A division of GST Corporation Limited) | NOIDA Uttar Pradesh, India | Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infitek Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Biotechnical, SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Kangjian Medical Apparatus Co., Ltd. | JIANGYAN Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kit Company | Phoenix, AZ, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lab Fish Equipment (zhejiang) Co,,ltd | Huzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Labpeak Co.,ltd | Jinan Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LW Scientific, Inc. | Lawrenceville, GA, United States | Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 1 | 0 | api.fda.gov | |
| Mark Enterprises | Nashik Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marken Healthtech Limited | NASHIK Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDTOX Diagnostics, Inc. | Pleasanton, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mida Precision Mold Corporation | My Yen Commune Tay Ninh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novem Medical S. De R.L. De C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nuo Therapeutics, Inc. | Houston, TX, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nuve Sanayi Malzemeleri Imalat Ve Ticaret A.S. | Ankara, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthoascent LLC | Westminster, CO, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| P Bhogilal Pvt Ltd | Kolkata West Bengal, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pall Newquay | Newquay Cornwall, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paul E. Danchell A/S | Jyderup Sjaelland, Denmark | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pfau Medizinische Instrumente GMBH | WANFRIED Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro-Tech Design & MFG., Inc. | Santa Fe Springs, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pall International, Sarl | Fribourg, Switzerland | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Reapplix | Birkerod Sjaelland, Denmark | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| REGEN LAB Sa | LE MONT-SUR-LAUSANNE Vaud, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rudolf Storz GMBH | EMMINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RWD Life Science Co., Ltd. | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remi Elektrotechnik Ltd. | Dist. Palghar Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sarstedt AG & Co. KG | NUMBRECHT North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sarstedt, Inc. | Newton, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scitek Global Co.,ltd | Jinan Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Lu Xiangyi Centrifuge Instrument Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Youding International Trade Co., Ltd. | Shanghai, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sia Elmi | Riga, Latvia, Latvia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sichuan Shuke Instrument Co.,ltd | Chengdu Sichuan, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sigma Laborzentrifugen GMBH | OSTERODE Lower Saxony, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stanbio Laboratory | Boerne, TX, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Syntr Health Technologies, Inc. | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sysmex Corporation Techno Park | KOBE Hyogo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Gene Era Bio-Science Co., Ltd. | Fengxian Shanghai, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SpineSmith Holdings, LLC | Austin, TX, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sysmex RA Co., LTD, Main Office | Shiojiri Nagano, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecan Schweiz AG | MAENNEDORF ZUERICH Zurich, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| THERMO ELECTRON LED GmbH | OSTERODE Lower Saxony, Germany | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tiger Medical Group | Shanghai, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuxi Nest Biotechnology Co., Ltd | Wuxi Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yantai Addcare Bio-Tech Co., Ltd. | Yantai Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Huawei Scientific Instrument Co Ltd | LinHai Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Lidesen Medical Instrument Co., Ltd | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Saining Biotechnology Co.,ltd | Taizhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhuhai Longtime Biological Technology Co., Ltd. | Zhuhai City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zien Medical Technologies LLC | Salt Lake City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zenith Lab (Jiangsu) Co.,LTD | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.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.