PaloDEx Group Oy

Devices placed in 32 countries

• Finland77
• Austria75
• Belgium75
• Bulgaria75
• Cyprus75
• Czechia75
• Germany75
• Denmark75
• Estonia75
• Spain75
• France75
• Greece75
• Croatia75
• Hungary75
• Ireland75
• Iceland75
• Italy75
• Liechtenstein75
• Lithuania75
• Luxembourg75
• Latvia75
• Malta75
• Netherlands75
• Norway75
• Poland75
• Portugal75
• Romania75
• Sweden75
• Slovenia75
• Slovakia75
• Türkiye75
• XI75

5 contacts identified

• HR
  HARJUNPÄÄ Rainer

  PRRC
  View profile →
• HR
  HARJUNPÄÄ Rainer

  PRRC
  View profile →
• NP
  NOUSIAINEN Päivi

  PRRC
  View profile →
• HARJUNPÄÄ Rainer
  - The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. -The reporting obligations are referred to in Articles 87 and 91 are filled. -In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II or Annex XV is issued.
  Hidden
• NOUSIAINEN Päivi
  -The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. -The post-market surveillance obligations are completed with in accordance with Article 10(10).
  Hidden

• Finnish Medicines Agency, Supervision and licences, Medical Device Unit
  FinlandContact the authority →

• PaloDEx Group Oy — FI-AR-000004955
• PaloDEx Group Oy — FI-IM-000004964
• PaloDEx Group Oy — FI-MF-000004943
• Eurofins Electric & Electronics Finland Oy — 1 certificate — PaloDEx Group Oy
• — represents — FI-AR-000004955
• — PaloDEx Group Oy
• — PaloDEx Group Oy
• — PaloDEx Group Oy