FDA registered
FDA registered
認証および規制上の地位
ISO 13485:2016
ISO 13485:2016
EN/ISO 13485:2016
EN/ISO 13485:2016
Directive 93/42/EEC
Directive 93/42/EEC
MDSAP (Australia, Brazil, Canada, United States)
MDSAP (Australia, Brazil, Canada, United States)
MDD class II and III
MDD class II and III
MDR pending
MDR pending