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Data / Medical devices / Light, Microscope

Light, Microscope (IBJ): 43 FDA-registered makers in 11 countries

43 establishments in 11 countries are registered with the FDA to make Light, Microscope (product code IBJ, Class 1, 21 CFR 864.3600). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on April 25, 1988, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
IBJ
Device class
1
Regulation
864.3600
Medical specialty
Pathology

Makers by country

CountryMakers
China19
United States5
Japan5
Germany4
India3
South Korea2
Israel1
Pakistan1
Canada1
Italy1
Taiwan1

Makers of Light, Microscope

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, IndiaSpecification developer0000api.fda.gov
AESKU.DIAGNOSTICS GmbH&Co.KGWENDELSHEIM Rhineland-Palatinate, GermanyManufacturer0000api.fda.gov
Apothecaries Sundries MFG Pvt LtdGURUGRAM Haryana, IndiaManufacturer0000api.fda.gov
Applied Spectral Imaging, Ltd.Yokneam Northern, IsraelManufacturer0000api.fda.gov
Asp Health Inc.Northbrook, IL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Alltion (Guangxi) Instrument Co., Ltd.Wuzhou City Guangxi, ChinaManufacturer0000api.fda.gov
CITOTEST Labware Manufacturing CO., LTD.Haimen Jiangsu, ChinaManufacturer0000api.fda.gov
Citotest Scientific Co.,ltd.Nanjing Jiangsu, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Cohen Industry Co., Ltd.Kitakata Fukushima, JapanContract manufacturer0000api.fda.gov
Carl Zeiss Microscopy, GmbHJena Thuringia, GermanyManufacturer0000api.fda.gov
Carl Zeiss Suzhou Co., Ltd.Suzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Evident CorporationKamiina-gun Nagano, JapanSpecification developer0000api.fda.gov
Evident CorporationHachioji-shi Tokyo, JapanComplaint file establishment, Specification developer0000api.fda.gov
Evident GuangZhou Co., Ltd.Guangzhou Guangdong, ChinaContract manufacturer0000api.fda.gov
Evident Nagano CorporationKamiina-gun Nagano, JapanContract manufacturer0000api.fda.gov
Foshan Soco Precision Instrument Co.,ltd.Foshan Guangdong, ChinaManufacturer0000api.fda.gov
Fotofinder Systems GMBHBAD BIRNBACH Bavaria, GermanyManufacturer0000api.fda.gov
Hangzhou Diagens Biotechnology Co., Ltd.Hangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
High Technology, Inc.North Attleboro, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Infitek Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Jiashan Yingjie Electron Co LtdJiashan Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Labotech Microscopes India Private LimitedAMBALA CANTT Haryana, IndiaManufacturer0000api.fda.gov
Labpeak Co.,ltdJinan Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Leica Microsystems CMS GMBHWETZLAR Hesse, GermanyManufacturer0000api.fda.gov
Leica Instruments (Shanghai) Co., Ltd.Shanghai, ChinaContract manufacturer0000api.fda.gov
Medical Devices (pvt) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
MEDIKAN CO., Ltd.Gangseo-gu Seoul, South KoreaManufacturer0000api.fda.gov
Metaoptima Technology Inc.Vancouver British Columbia, CanadaManufacturer0000api.fda.gov
Mikroscan Technologies IncVista, CA, United StatesManufacturer0000api.fda.gov
Motic China Group Co LtdXIAMEN Fujian, ChinaContract manufacturer, Foreign private label distributor, Manufacturer0000api.fda.gov
Nanjing Jiangnan Novel Optics Co., Ltd.Nanjing Jiangsu, ChinaContract manufacturer0000api.fda.gov
Nanjing Nikon Jiangnan Optical Instrument Co., Ltd.Nanjing Jiangsu, ChinaContract manufacturer0000api.fda.gov
Nikon CorporationSHINAGAWA-KU Tokyo, JapanManufacturer, Specification developer0000api.fda.gov
Ningbo Haishu District Proway Imp. & Exp. Co., Ltd.Ningbo Zhejiang, ChinaExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
NTP Nano Tech Projects SRLSant'Angelo in Vado Pesaro e Urbino, ItalyManufacturer0000api.fda.gov
Noul Co., Ltd.Yongin Si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Sakura Finetek U.s.a., Inc.Torrance, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Scitek Global Co.,ltdJinan Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Youding International Trade Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shenzhen GSD Tech Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Margotan Tech Co., Ltd.shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
TransliteSugar Land, TX, United StatesManufacturer, Specification developer0000api.fda.gov
Wellgen Medical Co., LtdKaohsiung City, TaiwanComplaint file establishment, Manufacturer0000api.fda.gov

Updated April 25, 1988. 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.