Ikegami Tsushinki Co.,Ltd.
Japan JP-MF-000025149 Last updated 8 Jun 2026
- Devices
- 12
- Registries
- EUDAMEDFDA
- FDA recalls
- 0
Catalogue
Mkc-835S Ref 003196/0
Mlw-2190HD Ref 110251/0
Mlw-2170HD Ref 110243
Mkc-X200 Ref 003123
Mkc-X300 Ref 003048
Mkc-X800 Ref 003047
Mdr-600HD Ref 110189/0
Mdr-600HD-A Ref 110204
Mlw-2623C-Dc Ref 110246/0
Mkc-750UHD Type H Ref 003170
Mlw-2760C Ref 110250/0
Mlw-3225C-3D Ref 110239
FDA establishments
- 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.
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.
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.
Information
- Country
- Japan
- Address
- 5-6-16, Ikegami, Ohta-ku, Tokyo, Japan
- Website
- www.ikegami.co.jp/en/
- facebook.com/ikegami.electronics
- [email protected]
- Phone
- +81286603314
- PRRC contact
- Shinich Tsugawa
- EUDAMED SRN
- JP-MF-000025149