Omni Lens Pvt Ltd

• Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten
  BelgiumContact the authority →

No certificates registered for this manufacturer.

5 contacts identified

• BN
  BATADA Norin

  PRRC
  View profile →
• PH
  PARIKH Helly

  PRRC
  View profile →
• BATADA Norin
  The main responsibilities are the one mentioned on Article 15 of the EU MDR 2017/745. Responsible to ensure :Conformity of the product device to the Medical Device Regulation and quality Management System, Technical Documentation and EU Declaration of conformity, Post-Market Surveillance (PMS) following Article 10(10), the Vigilance Reporting obligations (Article 87 to 91). For investigational devices: lssuance of a signed statement (Annex XV chapter ll section 4.1)
  Hidden
• PARIKH Helly
  The main responsibilities are the one mentioned on Article 15 of the EU MDR 2017/745. Responsible to ensure :Conformity of the product device to the Medical Device Regulation and quality Management System, Technical Documentation and EU Declaration of conformity, Post-Market Surveillance (PMS) following Article 10(10), the Vigilance Reporting obligations (Article 87 to 91). For investigational devices: lssuance of a signed statement (Annex XV chapter ll section 4.1)
  Hidden
• SUTHAR Mita
  The main responsibilities are the one mentioned on Article 15 of the EU MDR 2017/745. Responsible to ensure :Conformity of the product device to the Medical Device Regulation and quality Management System, Technical Documentation and EU Declaration of conformity, Post-Market Surveillance (PMS) following Article 10(10), the Vigilance Reporting obligations (Article 87 to 91). For investigational devices: lssuance of a signed statement (Annex XV chapter ll section 4.1)
  Hidden

• BATADA Norin — Omni
• PARIKH Helly — Omni

No devices registered for this manufacturer.