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.
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- Product code
- IBJ
- Device class
- 1
- Regulation
- 864.3600
- Medical specialty
- Pathology
Makers by country
| Country | Makers |
|---|---|
| China | 19 |
| United States | 5 |
| Japan | 5 |
| Germany | 4 |
| India | 3 |
| South Korea | 2 |
| Israel | 1 |
| Pakistan | 1 |
| Canada | 1 |
| Italy | 1 |
| Taiwan | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Accuster Technologies Pvt. Ltd. | New Delhi, India | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AESKU.DIAGNOSTICS GmbH&Co.KG | WENDELSHEIM Rhineland-Palatinate, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apothecaries Sundries MFG Pvt Ltd | GURUGRAM Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Applied Spectral Imaging, Ltd. | Yokneam Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Asp Health Inc. | Northbrook, IL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alltion (Guangxi) Instrument Co., Ltd. | Wuzhou City Guangxi, China | 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 | |
| Cohen Industry Co., Ltd. | Kitakata Fukushima, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carl Zeiss Microscopy, GmbH | Jena Thuringia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carl Zeiss Suzhou Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evident Corporation | Kamiina-gun Nagano, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evident Corporation | Hachioji-shi Tokyo, Japan | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evident GuangZhou Co., Ltd. | Guangzhou Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evident Nagano Corporation | Kamiina-gun Nagano, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Soco Precision Instrument Co.,ltd. | Foshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fotofinder Systems GMBH | BAD BIRNBACH Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Diagens Biotechnology Co., Ltd. | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| High Technology, Inc. | North Attleboro, MA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infitek Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiashan Yingjie Electron Co Ltd | Jiashan Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Labotech Microscopes India Private Limited | AMBALA CANTT Haryana, India | 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 | |
| Leica Microsystems CMS GMBH | WETZLAR Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leica Instruments (Shanghai) Co., Ltd. | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Devices (pvt) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDIKAN CO., Ltd. | Gangseo-gu Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Metaoptima Technology Inc. | Vancouver British Columbia, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mikroscan Technologies Inc | Vista, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Motic China Group Co Ltd | XIAMEN Fujian, China | Contract manufacturer, Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanjing Jiangnan Novel Optics Co., Ltd. | Nanjing Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanjing Nikon Jiangnan Optical Instrument Co., Ltd. | Nanjing Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nikon Corporation | SHINAGAWA-KU Tokyo, Japan | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Haishu District Proway Imp. & Exp. Co., Ltd. | Ningbo Zhejiang, China | Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| NTP Nano Tech Projects SRL | Sant'Angelo in Vado Pesaro e Urbino, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Noul Co., Ltd. | Yongin Si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sakura Finetek U.s.a., Inc. | Torrance, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 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 Youding International Trade Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen GSD Tech Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Margotan Tech Co., Ltd. | shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Translite | Sugar Land, TX, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wellgen Medical Co., Ltd | Kaohsiung City, Taiwan | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.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.