Europe
Struer, Denmark
Innovation & Development Center
Employees
Engineers and operations
Total Footprint
95,800 ft2 (8,900 m2)
Cleanroom(s)
Class 8
Certifications
EN ISO 13485:20216
(EU) 2017/745 Medical Device Regulation
Directive 93/42/EEC MDSAP (AU/BR/CA/JP/US)
UKCA (UK)
INMETRO (BR)
Registrations
FDA 21 CFR 20
MHLW Foreign Manufacturer
Manufacturing Volume
100,000 EAU, Medium: 1,000,000 (molding)
Manufacturing Complexity
High complexity low volume assembly, packaging