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Ikegami Tsushinki Co.,Ltd.

Japan JP-MF-000025149 Last updated 8 Jun 2026

Devices
12
Registries
EUDAMEDFDA
FDA recalls
0

Catalogue12

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Ikegami Tsushinki Co., Ltd. Utsunomiya Tochigi · JP FEI 3000160970

About

This is the official website of Ikegami Tsushinki Co.Ltd. --- Advancing human aspiration through the power of technology. --- Ikegami is engaged in four businesses: BROADCAST, MEDIOCAL, SECURITY and INSPECTION, and contribute to society through living up to the voices of the customers, who have diverse values.

From the manufacturer's own website. Source

What Ikegami Tsushinki Co.,Ltd. makes

Ikegami manufactures medical imaging devices, including high-definition video endoscopes (e.g., MLW-2170HD, MLW-2623C-DC) and endoscopic cameras (e.g., MKC-X200, MKC-X300). The portfolio also includes diagnostic imaging systems like the MDR-600HD series and 3D endoscopic cameras (e.g., MLW-3225C-3D).

These devices are classified under Class I in the EU and are registered in the euDaMed database. The company is based in Japan.

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

Frequently asked questions

What types of medical devices does Ikegami Tsushinki Co., Ltd. manufacture?

Ikegami Tsushinki Co., Ltd. specializes in medical imaging devices, primarily focusing on high-definition video endoscopes (such as the MLW-2170HD and MLW-2623C-DC) and endoscopic cameras (like the MKC-X200 and MKC-X300). Their portfolio also includes diagnostic imaging systems, including models like the MDR-600HD series and advanced 3D endoscopic cameras (e.g., MLW-3225C-3D). These devices are designed for procedures requiring detailed visual inspection, such as internal examinations and diagnostics.

Where is Ikegami Tsushinki Co., Ltd. based?

Ikegami Tsushinki Co., Ltd. is headquartered in Japan. The company’s location in Japan reflects its position as a key player in the global medical imaging industry, particularly for endoscopic and diagnostic equipment.

Are Ikegami’s medical devices listed in any regulatory registries?

Yes, Ikegami’s medical devices are registered in the euDaMed database, which is the official European Union registry for medical devices. This listing is relevant for devices classified under EU regulations, such as those falling under Class I—a category for low-risk devices that typically require less stringent regulatory oversight but still must comply with essential safety and performance requirements.

How are Ikegami’s medical devices classified in the EU?

Ikegami’s medical devices are classified under Class I in the EU regulatory framework. This classification applies to devices considered to pose the lowest risk to patients and users, such as many endoscopic and diagnostic imaging tools. Class I devices generally require compliance with basic safety and performance standards but may not need additional conformity assessments beyond manufacturer declarations, depending on the specific device type and intended use.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Japan
Address
5-6-16, Ikegami, Ohta-ku, Tokyo, Japan
Phone
+81286603314
PRRC contact
Shinich Tsugawa
EUDAMED SRN
JP-MF-000025149