GFI Health Technology Certification, based in Nicosia, Cyprus, has been listed as the EU’s 39th notified body in the context of the EU Medical Device Regulation.
Its designation is limited to 19 product codes and includes: reusable surgical instruments; devices incorporating medicinal substances (but excluding medicinal products derived from human blood or human plasma; class III custom-made implantable devices, but limited to orthopaedic and ophthalmological devices; devices incorporating software/utilizing software/controlled by software, including devices intended for controlling, monitoring or directly influencing the
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