Vivasure Medical Ltd.

• Health Products Regulatory Authority, Medical Devices Department
  IrelandContact the authority →

Devices placed in 22 countries

• Austria2
• Belgium2
• Cyprus2
• Czechia2
• Germany2
• Denmark2
• Spain2
• Finland2
• France2
• Greece2
• Ireland2
• Iceland2
• Italy2
• Liechtenstein2
• Luxembourg2
• Malta2
• Netherlands2
• Norway2
• Poland2
• Portugal2
• Sweden2
• Türkiye2

6 contacts identified

• CB
  CLOONAN Brian

  PRRC
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• LL
  LEACH Lorna

  PRRC
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• MC
  MARTIN Chris

  PRRC
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• LEACH Lorna
  Vivasure compliance with Regulation (EU) 2017/745, with specific emphasis on Article 15 (3) (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with Article 10(10); (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled
  Hidden
• CLOONAN Brian
  Vivasure compliance with Regulation (EU) 2017/745, with specific emphasis on Article 15 (3) (a) 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;
  Hidden
• MARTIN Chris
  Vivasure compliance with Regulation (EU) 2017/745, with specific emphasis on Article 15 (3) (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued
  Hidden

• Vivasure Medical Ltd. — IE-MF-000000651
• Vivasure Medical Ltd. — IE-PR-000011259
• TÜV SÜD Product Service GmbH — 2 certificates — Vivasure Medical Ltd.
• CLOONAN Brian — Vivasure Medical Ltd.
• LEACH Lorna — Vivasure Medical Ltd.
• MARTIN Chris — Vivasure Medical Ltd.