Lombard Medical Limited

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

Devices placed in 22 countries

• Austria1000
• Cyprus1000
• Germany1000
• Spain1000
• Greece1000
• Hungary1000
• Italy1000
• Netherlands1000
• Norway1000
• Poland1000
• Romania1000
• Sweden1000
• Slovakia1000
• Finland999
• Czechia994
• Denmark994
• Ireland994
• Croatia988
• Latvia12
• Estonia7
• Lithuania6
• Türkiye6

5 contacts identified

• BM
  BURDEN Matthew

  PRRC
  View profile →
• FM
  FLETCHER Mark

  PRRC
  View profile →
• BURDEN Matthew
  - the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; - the post-market surveillance obligations are complied with in accordance with Article 10(10); - the reporting obligations referred to in Articles 87 to 91 are fulfilled; - in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
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• FLETCHER Mark
  ensuring that 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
• TSIOURIS Konstantinos
  - the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; - the post-market surveillance obligations are complied with in accordance with Article 10(10); - the reporting obligations referred to in Articles 87 to 91 are fulfilled; - in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
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• DQS Medizinprodukte GmbH — 3 certificates — Lombard Medical Limited
• Medical Device Management Ltd — represents — Lombard Medical Limited
• BURDEN Matthew — Lombard Medical Limited
• FLETCHER Mark — Lombard Medical Limited