Ellex Medical Pty Ltd

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

Devices placed in 32 countries

• France27
• Poland21
• Spain20
• Italy20
• Netherlands20
• Belgium19
• Czechia19
• Germany18
• Portugal18
• Bulgaria17
• Latvia17
• Sweden17
• Finland16
• Slovakia16
• Türkiye16
• Austria15
• Greece15
• Hungary15
• Romania15
• Cyprus14
• Denmark14
• Estonia14
• Croatia14
• Ireland14
• Iceland14
• Liechtenstein14
• Lithuania14
• Luxembourg14
• Malta14
• Norway14
• Slovenia14
• XI14

3 contacts identified

• PR
  PRRC
• PILLAY Rashmi
  The Head of Regulatory shall be responsible for • the technical documentation and the EU declaration of conformity are drawn up and kept up to date. • the reporting obligations referred to in Articles 87 to 91 EU MDR are fulfilled.
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• TAWAASH Aya
  The Head of Quality shall be responsible for • the conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured before a device is released. • the post-market surveillance obligations are compiled in accordance with Article 10(10) EU MDR requirements.
  Hidden

No certificates registered for this manufacturer.

• E C REP LIMITED — represents — Ellex
• PILLAY Rashmi — Ellex