European quality. Made in Austria 50 pcs /pack, boxed Medical products produced directly in Austria Type IIR face masks. Efficiency > 98% tested and confirmed by Nelson Labs, USA. Type IIR according to EN 14683:2019 +AC:2019 for medical face masks. Class I according to Regulation (EU) 2017/745 for medical devices (MDR), UMDNS code: 12-458. Listed as a medical device in Europe with its own pharmaceutical central number and CE marked.