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 #24820248
- India license # IMP/MD/2023/001383
suiteHEART® is available in the following markets:
Africa
Egypt
South Africa
Asia
Armenia
Azerbaijan
Hong Kong
India
Iraq
Israel
Lebanon
Mongolia
Nepal
Turkey
United Arab Emirates
Vietnam
Europe
Austria
Belgium
Republic of Cyprus
Estonia
Finland
France
Germany
Greece
Iceland
Ireland
Italy
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Poland
Portugal
Romania
Spain
Sweden
Switzerland
United Kingdom
North America
Canada
United States
Oceania
Australia
New Zealand
South America
Brazil
Chile
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]
