Company

Mona Lisa N.V., a member of the EurimPharm group, has been manufacturer of medical devices for more than 30 years. It is specialized on medical devices class II and III for the field of gynecology. The business fields of Mona Lisa N.V. encompass:

Business

Copper-Intrauterine-Devices (IUD)

Mona Lisa produces according to ISO 13485:2003, CAN/CSA ISO 13485:2003 and EN ISO 13485:2012 generic versions of all current copper IUDs and distributes them worldwide.

Consultation services / submanufacturing services

Due to its longyear experiences Mona Lisa N.V. offers consultation and support in all questions concerning:

  • Quality management (ISO 13485:2003, EN ISO 13485:2012)
  • Technical files for all CE products of class II, III
  • Technical drawings for special moulds of medical devices

Please do not hesitate to contact us for consultation.

Philosophy

The main concern of Mona Lisa is the leadership in quality with all its products and services. Regular quality controls of our suppliers, controls during production processes as well as controls before final release guarantee highest quality. Mona Lisa N.V. is certified according to ISO 13485:2003, CAN/CSA ISO 13485:2003 and EN ISO 13485:2012.

Our lower-priced generic products help patients as well as national health care systems to create savings.

History

Mona Lisa N.V. was founded in 1996. Until then the company was known as "Homesteel-Achel" which was the exclusive sub manufacturer for Organon from 1980-1996. In that time the company produced the complete line of Multiload® for all markets in the world (approx. 10 Million IUDs). Furthermore, all clinical studies for Multiload® were done with the products by Homesteel-Achel / Mona Lisa. Since 1996 Mona Lisa produces and distributes its own generic line of copper IUDs. Today, all relevant personnel still works for Mona Lisa N.V. In addition, in 1996 Mona Lisa established a quality management system and, since then, produces according to ISO 13485:2003, CAN/CSA ISO 13485:2003 and EN ISO 13485:2012.

More than 30 years of know-how, ISO-certification and longtime establishment on the market guarantee highest quality of all Mona Lisa IUDs and make them one of the leading and best proven generic copper IUDs worldwide.

History:

  • 1996: Foundation of the Company Mona Lisa N.V.
  • 1996: Market entry with the rebuilt of the Multiload Cu 250, Cu 375 in Portugal, Switzerland and Israel
  • 1997: Rebuilt of the Classic Copper TCu 200 / 380 / Gyne T 200/380
  • 1998: Market entry in Germany with the rebuilts of Multiload Cu 250, Cu 375 and the rebuilt of T Cu 200 / 380
  • 1999: Market entry in Austria, Hungary
  • 1999: Sub manufacturer for the Company Schering Spain. Development and sub manufacturing of aspiration needles for the company Gynotec, Netherlands.
  • 2000: Market entry in UK; Rebuilt of the Nova T 380
  • 2001: Market penetration of the rebuilt of the Nova T 380 in all mentioned markets
  • 2002: Rebuilt of the Multiload Cu 375 short loop; Market entry in Italy
  • 2003: Market penetration of the rebuilt of the Multiload Cu 375 short loop in all mentioned markets
  • 2004: Market entry in Ireland and Belgium
  • 2005: Market entry in France
  • 2006: Market entry in Denmark
  • 2007: Market entry in Greece, Turkey
  • 2008: Market entry with the rebuilt of the Flexi T 300 in all mentioned markets
  • 2009: Market entry in Hong Kong, Latvia, Poland, Serbia, Spain, The Netherlands
  • 2010: Market entry in Norway, Czech Republic, Kuwait, United Arab Emirates. Submanufacturing of "Gynefix" for the company Contrel, Belgium
  • 2011: Market entry in Canada
  • 2013: Market entry in South Africa, Tunisia, Malaysia
  • 2014: Development and manufacturing of the NT Cu380 Mini, a smaller version of the Nova T-rebuilt. Market launch of the NT Cu380 Mini in the mentioned markets
  • 2018: Market entry in Iran and Australia.

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