This page provides products information complied medical device requirements in EEA & UK.

Quality Standards

Our approach to quality improvement on medical devices.

Based on our technique as a foundation of experience over 70 years in micromanipulation under a microscope in basic research laboratories, we Narishige have always been a leader in the industry. With a history of long and close communication with researchers in various microscopic worlds, we have provided basic technology for various applications, including Intracytoplasmic Sperm Injection (ICSI), in many animal species.

We have established the medical division of Narishige Group, Narishige Lifemed Co.,Ltd. to contribute to the medical field. We will provide quality medical products to people around the world so that they can have a better life. Backed by use in a diversity of life science research conducted in many facilities, our products are manufactured strictly in accordance with ISO 13485, Europe and USA medical device regulations.

-Narishige Lifemed CEO Mitsuko Narishige-

MDR

Medical Device Regulation

The products in this website are complied with the requirements of Regulation (EU) 2017/745.

Countries:

  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czech Republic
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden

UK MDR 2002

The Medical Devices Regulations 2002

The products in this website are complied with the requirements of UK MDR 2002(SI 2002 No.618, as amended).

Country:

  • UK

* Not including Northern Ireland on this regulation.

ISO13485

Quality management systems

The products in this website are manufactured and serviced based on quality management systems of the ISO13485:2016.
Narishige Lifemed Co., Ltd. as manufacturer in Japan is a company which has been certified by Notified Body.