EU Medical Device Regulation (MDR) 2017/745

Picterus AS is the legal manufacturer of a class IIa medical device, the Picterus® Jaundice Pro, and a class I medical device, the Picterus Calibration Card. Picterus AS is certified under the European Medical Device Regulation 2017/745 and holds the following certificates:

ISO 13485

EU Quality Management Certificate

CE-0297