MDR: 47th Notified Body on NANDO!

The NANDO database has a new Notified Body under the MDR!

MTIC InterCert S.r.l. is the 47th EU Notified Body notified under Regulation (EU) 2017/745 on medical devices – MDR.

MTIC InterCert S.r.l.

Sede Legale: Via G.Leopardi, 14 – Sede Operativa: Via Moscova, 11

20123 – Milano (MI) – 20017 – Rho (MI)

Italy

+39 02 97071800

info@mtic-group.org

www.mtic-group.org

Body Number: 0068

The extract from the Notification:

  • MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
    • Excluding class III Medical Devices
  • MDA 0204 Other active non-implantable devices for monitoring and/or diagnosis
    • Excluding class III Medical Devices
  • MDA 0302 Active non-implantable devices utilising non-ionizing radiation
    • Excluding class III Medical Devices
  • MDA 0303 Active non-implantable devices utilising hyperthermia/hypothermia
    • Excluding class III Medical Devices
  • MDA 0305 Active non-implantable devices for stimulation or inhibition
    • Excluding class III Medical Devices
  • MDA 0313 Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport
    • Excluding class III Medical Devices
  • MDA 0315 Software
    • Excluding class III Medical Devices
  • MDA 0317 Active non-implantable devices for cleaning, disinfection and sterilisation
  • MDA 0318 Other active non-implantable devices
    • Excluding class III Medical Devices
  • MDN 1103 Non-active dental implants and dental materials
    • Excluding class III Medical Devices
  • MDN 1203 Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools
    • Excluding class III Medical Devices
  • MDS 1005 Devices in sterile condition
    • Including: – ethylene oxide gas sterilisation (EOG) – low temperature steam – moist heat sterilisation – radiation sterilisation (gamma-ray, x-ray)
  • MDS 1006 Reusable surgical instruments
  • MDT 2012 Devices which require installation, refurbishment
    • Limited to devices which require installation
  • MDT 2013 Devices which have undergone reprocessing
    • Limited to reusable devices which have to undergone reprocessing

The full designation scope is available here.

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