suiteHEART® is registered in the following markets:
- USA – 510k #K130228
- Canada – Medical Device License #99490
- European Union – CE Certificate #618294
- Malaysia – Registration No. GB10979720-50888
- New Zealand – Medsafe WAND Reference: 160505-WAND-6LXEGH
- United Arab Emirates – MOHAP Application No. DRCLAS-2020-000474
- Australia ARTG Identifier 407410
- Brazil ANVISA No 80117581022
- Israel Certificate 55483
suiteHEART® is available in the following countries:
Austria, Azerbaijan, Belgium, Canada, Chile, Cyprus, Egypt, Estonia, Finland, France, Germany, Greece, Iceland, India, Ireland, Italy, Liechtenstein, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Netherlands, New Zealand, Portugal, Romania, South Africa, Spain, Sweden, Switzerland, Turkey, UAE, UK, USA, Vietnam
NeoSoft holds the following Quality Management System Certificates:
- ISO 13485:2016 No. FS 704544 and No. MDSAP 689720
For further market information, please contact: [email protected]
