HeartSine Technologies Ltd

• The Medicines and Healthcare Products Regulatory Agency
  XIContact the authority →

8 contacts identified

• BJ
  BELL John

  PRRC
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• HA
  HARVEY Adam

  PRRC
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• LK
  LOCKHART Karen

  PRRC
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• QO
  QUINN Oisin

  PRRC
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• LOCKHART Karen
  (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
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• BELL John
  (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; NOTE: This refers to Vigilance reporting, i.e. serious incident, field safety corrective action, and incident trend reporting).
  Hidden
• HARVEY Adam
  (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
  Hidden
• QUINN Oisin
  (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;
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Devices placed in 31 countries

• XI5
• Austria3
• Belgium3
• Cyprus3
• Czechia3
• Germany3
• Denmark3
• Estonia3
• Spain3
• Finland3
• France3
• Greece3
• Croatia3
• Hungary3
• Ireland3
• Italy3
• Lithuania3
• Luxembourg3
• Latvia3
• Malta3
• Netherlands3
• Norway3
• Poland3
• Portugal3
• Romania3
• Sweden3
• Slovenia3
• Slovakia3
• Iceland1
• Liechtenstein1
• Türkiye1

• TÜV SÜD Product Service GmbH — 2 certificates — HST
• BELL John — HST
• HARVEY Adam — HST
• LOCKHART Karen — HST
• QUINN Oisin — HST