MDR: 38th Notified Body on NANDO!

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

SZUTEST Konformitätsbewertungsstelle GmbH is the 38th EU Notified Body under the Regulation (EU) 2017/745 on medical devices – MDR:

SZUTEST Konformitätsbewertungsstelle GmbH
Friedrich-Ebert-Anlage 36
D-60325 Frankfurt am Main
Country : Germany
Phone : +49 69 244 333 026
Email : info@szutest-germany.de
Website : http://www.szutest-germany.de
Notified Body number : 2975

You can find the full scope of its notification on the following link. Below, an extract from NANDO, where conditions/limitations are listed:

Codes reflecting the design and intended purpose of the device

A. Active devices

2. Active non-implantable devices for imaging, monitoring and/or diagnosis

• • MDA 0202 Active non-implantable imaging devices utilising non-ionizing radiation
  • MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
  • MDA 0204 Other active non-implantable devices for monitoring and/or diagnosis

3. Active non-implantable therapeutic devices and general active non-implantable devices

• • MDA 0302 Active non-implantable devices utilising non-ionizing radiation
  • MDA 0305 Active non-implantable devices for stimulation or inhibition
  • MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis
  • MDA 0307 Active non-implantable respiratory devices
  • MDA 0308 Active non-implantable devices for wound and skin care
  • MDA 0309 Active non-implantable ophthalmologic devices
  • MDA 0310 Active non-implantable devices for ear, nose and throat
  • MDA 0311 Active non-implantable dental devices
  • MDA 0312 Other active non-implantable surgical devices
  • MDA 0313 Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport
  • …

B. Non-active devices

1. Non-active implants and long term surgically invasive devices

• • MDN 1101 Non-active cardiovascular, vascular and neurovascular implants
  • MDN 1102 Non-active osteo- and orthopaedic implants
  • MDN 1103 Non-active dental implants and dental materials
  • MDN 1104 Non-active soft tissue and other implants

2. Non-active non-implantable devices

• • MDN 1201 Non-active non-implantable devices for anaesthesia, emergency and intensive care
  • MDN 1202 Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis
  • MDN 1203 Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools
  • MDN 1204 Non-active non-implantable devices for wound and skin care
  • MDN 1206 Non-active non-implantable ophthalmologic devices
  • MDN 1208 Non-active non-implantable instruments
  • MDN 1209 Non-active non-implantable dental materials
  • MDN 1211 Non-active non-implantable devices for disinfecting, cleaning and rinsing
  • MDN 1213 Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route
  • MDN 1214 General non-active non-implantable devices used in health care and other non-active non-implantable devices

Horizontal technical competence

• MDS 1001 Devices incorporating medicinal substances
• MDS 1004 Devices which are also machinery as defined in point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council (1)
• MDS 1005 Devices in sterile condition
  • Limitations: aseptic processing; ethylene oxide gas sterilisation (EOG); moist heat sterilisation; radiation sterilisation (gamma, x-ray, electron beam)
• MDS 1006 Reusable surgical instruments
• MDS 1007 Devices incorporating or consisting of nanomaterial
• MDS 1007 Devices incorporating or consisting of nanomaterial
• MDS 1009 Devices incorporating software/utilising software/controlled by software, including devices intended for controlling, monitoring or directly influencing the performance of active or active implantable devices
• MDS 1010 Devices with a measuring function
• MDS 1011 Devices in systems or procedure packs
• …