Exact Imaging Inc.

• Ministerie van Volksgezondheid, Welzijn en Sport
  NetherlandsContact the authority →

No certificates registered for this manufacturer.

Devices placed in 32 countries

• Austria1
• Belgium1
• Bulgaria1
• Cyprus1
• Czechia1
• Germany1
• Denmark1
• Estonia1
• Spain1
• Finland1
• France1
• Greece1
• Croatia1
• Hungary1
• Ireland1
• Iceland1
• Italy1
• Liechtenstein1
• Lithuania1
• Luxembourg1
• Latvia1
• Malta1
• Netherlands1
• Norway1
• Poland1
• Portugal1
• Romania1
• Sweden1
• Slovenia1
• Slovakia1
• Türkiye1
• XI1

2 contacts identified

• AR
  AUCOIN Randy

  PRRC
  View profile →
• AUCOIN Randy
  1) the conformity of the devices is checked in accordance with the QMS under which the devices are manufactured before a device is released 2) technical documentation and the EU DoC are drawn up and kept up-to-date 3) PMS obligations are complied with in accordance with EU MDR Article 10(10); 4) reporting obligations referred to in EU MDR Articles 87 to 91 are fulfilled 5) in the case of investigational devices, the statement in EU MDR Section 4.1 of Chapter II of Annex XV is issued
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• Emergo Europe B.V. — represents — Exact Imaging Inc.
• AUCOIN Randy — Exact Imaging Inc.