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Otsuka Electronics Co., Ltd.

Japan JP-MF-000001943 Last updated 23 Oct 2026

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Devices
7
Registries
EUDAMEDFDA
FDA recalls
0

Catalogue7

Authorised representatives

About

大塚電子株式会社は、粒子径・ゼータ電位測定やマルチチャンネル分光器などの分析機器・医療機器(ME)の専門メーカーです。最先端の光計測技術で研究開発をサポートします。詳細はこちら。

From the manufacturer's own website, in their original language. Source

What Otsuka Electronics Co., Ltd. makes

Otsuka Electronics Co., Ltd. manufactures analytical instruments and medical devices, including particle diameter measurement systems, zeta potential analyzers, and multi-channel optical spectrometers. Their product line includes portable and benchtop devices like the POConePlus-AS10 and POConePlus Infrared Spectrophotometer, as well as specialized gas analyzers such as the Standard Gas and AA01. The company also produces optical density testers like the Adastand ODT-SC001 and the Adamonitor SC for research and diagnostic applications.

The company’s devices are classified under EU regulations as Class A, Class B, Class I, and Class IIb, with several listed in the EU’s eudamed registry. The manufacturer is based in Japan and adheres to applicable regulatory frameworks for each device class, ensuring compliance with international standards for medical and analytical instrumentation.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
Japan
Address
3-26-3, Shodai-Tajika, Hirakata-shi,, Osaka, Japan
Phone
+81 748 63 5454
PRRC contact
Toshiyuki Mori
EUDAMED SRN
JP-MF-000001943
FDA FEI number
3005622096
DUNS number
695318717