AIRS Medical Inc.

• Malta Medicines Authority
  MaltaContact the authority →

Devices placed in 17 countries

• Germany2
• Spain2
• Greece2
• Croatia2
• Italy2
• Norway2
• Poland2
• Austria1
• Cyprus1
• Denmark1
• Finland1
• France1
• Hungary1
• Netherlands1
• Portugal1
• Romania1
• Slovenia1

4 contacts identified

• KJ
  KWON Joanna

  PRRC
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• OH
  OH Helen

  PRRC
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• OH Helen
  1) The technical documentation and DoC are drawn up and kept up to date 2) 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 in 27 EU Member states**, Iceland, Norway, Lichtenstein, Northern Ireland and Turkey 3) the post-market surveillance obligations in accordance with Article 10(10) of MDR 4) the reporting obligations referred to in Articles 87 to 91 of MDR
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• KWON Joanna
  1) The technical documentation and DoC are drawn up and kept up to date 2) 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 in 27 EU Member states**, Iceland, Norway, Lichtenstein, Northern Ireland and Turkey 3) the post-market surveillance obligations in accordance with Article 10(10) of MDR 4) the reporting obligations referred to in Articles 87 to 91 of MDR
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• DNV Product Assurance AS — 1 certificate — AIRS Medical Inc.
• Scarlet NB B.V. — 1 certificate — AIRS Medical Inc.
• Advena Limited — represents — AIRS Medical Inc.
• KWON Joanna — AIRS Medical Inc.
• OH Helen — AIRS Medical Inc.