About OTU Medical
We are a platform medical device company with a leading position in the single-use urological endoscope segment, providing innovative visualization and minimally invasive medical devices. Operating in Silicon Valley and the PRC, we focus on the research, development, and commercialization of single-use endoscope systems. We stand as one of the very few companies worldwide to have successfully vertically integrated the supply chain for single-use endoscopes, encompassing the independent research and manufacturing of core optoelectronic components and precision parts through to the assembly of complete systems.
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Wise Digital was established in the PRC and later commenced the business of design, development and supply of endoscope components.
2000
2013
2014
2017
2018
2019
Wise OptoMech was established in the PRC and commenced the business of development and manufacture of disposable endoscopes and image processors.
Wise OptoMech was the champion in the advanced manufacturing category in the China Innovation & Entrepreneurship Competition.
OTU Medical was incorporated in the U.S. and commenced the business of design, manufacture and sale of endoscopes, thus expanding the reach of our products to the global market.
Our WiScope® Ureteroscope successfully received FDA 510(k) clearance.
2020
2021
2022
2024
2025
Wise OptoMech obtained the High-Tech Enterprise Certificate
We established our second manufacturing facility in Ningbo,Zhejiang.
We received EU MDD Certificate issued by TUV SUD ProductService GmbH for our digital endoscope system, single-use digitalflexible ureteroscope.
OTU Medical
Our Group achieved sales of over RMB100 million during the year.
Our WiScope® Ureteroscope successfully received NMPA Class IImedical device registration certificate.
Wise OptoMech received Medical Device Single Audit Program certification issued by TUV SUD America Inc.
OTU Medical received CE marking under the EU MDR issued byTUV SUD Product Service GmbH.
Following a GCP-related FDA inspection of our U.S. site, we received a "No Action Indicated" (NAl) classification, which is widely regarded as the most favorable FDA inspection classification.
Wise OptoMech was recognized as a "Little Giant" Enterprise.