suiteHEART® is registered in the following markets:
- USA – 510k #K130228
- Canada – Medical Device License #99490
- European Union – CE Certificate #618294
- 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 markets:
Armenia, Australia, Austria, Azerbaijan, Belgium, Brazil, Canada, Chile, Cyprus, Egypt, EU, Finland, France, Germany, Greece, Iceland, Ireland, Israel, Italy, Liechtenstein, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Mongolia, Netherlands, New Zealand, Poland, Portugal, Romania, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, United States, Estonia, Hong Kong, Iraq, Lebanon, Nepal, 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]
