Atlantico Systems, Ltd.

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

2 contacts identified

• BS
  BOND Sheena

  PRRC
  View profile →
• BOND Sheena
  Ensuring all requirements all of euMDR 2017/745 Article 15 are fulfilled for Atlantico Systems. a) The conformity of the devices has been appropriately assessed by the manufacturer. b) The technical documentation and the EU declaration of conformity are drawn up and copies maintained by Atlantico Systems. c) The post-market surveillance obligations are complied with in accordance with the requirement of the MDR d) Reporting obligations of Atlantico Systems are fulfilled.
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11 non-EU manufacturers

• Mirion Technologies (Capintec), Inc. 🇺🇸 US115 devices
• NICO Corporation 🇺🇸 US29 devices
• Chemence Medical Inc. 🇺🇸 US14 devices
• Koven Technology, Inc. 🇺🇸 US5 devices
• Biotech Inc 🇺🇸 US2 devices
• eKare Inc. 🇺🇸 US2 devices
• Precision Medical Devices, LLC 🇺🇸 US2 devices
• GOTOP Medical, Inc. 🇺🇸 US
• Oculogica Inc. 🇺🇸 US
• 🇺🇸 US
• 🇺🇸 US

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• — Atlantico Systems