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Quality & Regulatory Resources

ISO 13485:2016 AktiiaSA

Declaration of conformity

CE Certificate

Health Canada Medical Devices Active Licence Listing (MDALL)

This website is operated by Aktiia SA.

 

Headquarters address:
Rue du Bassin 8a,
Neuchâtel, 2000,
Switzerland

Aktiia PTY address:
3 Dolphin St,
Randwick
NSW 2031
Australia

Aktiia BV address:
Koetshuislaan 215
5146BM Waalwijk
Netherlands

Aktiia SA is legally represented by the Board of Directors (Josep Sola, Daniel Graf, Christoph Massner, Eric Hsia,Stefan Petzinger ).

Chairman of the Board of Directors: Stefan Petzinger

VAT Identification Number:
Aktiia SA: CHE-149.232.500
Aktiia BV: NL862305688B01

Registration Number:
Aktiia SA: CHE-149.232.500
Aktiia BV: 82016194

The information in this legal notice also applies to the following online presences of Aktiia SA:

Facebook

Instagram

YouTube

Twitter

LinkedIn

Hilo Backend – Regulatory Compliance

Intended Use:

The Hilo Backend is a Medical Device Software (MDSW) of the Hilo Spot system intended to run on cloud servers. It receives photoplethysmography (PPG) data transmitted from the Hilo App, processes the data using the Hilo Algorithm, and generates blood pressure and heart rate results which are then transmitted back to the Hilo App for display

The Hilo Backend is indicated for supporting home monitoring of blood pressure and heart rate in adult patients aged 21–85 years.

Product Name: Hilo Backend

UDI:

UDI-DI / Device Identifier: 17649998849132

UDI-PI / Production Identifier:

Version: v2.9.0

Date of Production (Date of build of the SW): 20260126

Aktiia SA, Rue du Bassin 8a,

2000 Neuchâtel,

Switzerland

Contact:

For any questions, contact support@aktiia.com.
+41 32 552 50 58

EU Importer:

Aktiia BV

Koetshuislaan 215,

5146 BM, Waalwijk

Netherlands

Veranex Germany GmbH

Landsberger Str. 302, D-80687

Munich, Germany

Emergo Australia

201 Sussex Street, Level 20

Tower II Darling Park

Sydney, NSW 2000, Australia

Responsible for content

Laetitia Dubief
Rue du Bassin 8a
2000 Neuchâtel
Switzerland

Hosting Provider

Shopify International Limited
Victoria Buildings, 2nd Floor
1–2 Haddington Road
Dublin 4, D04 XN32
Ireland

Symbols Glossary:

Manufacturer information
European Authorized Representative
Australian Authorized Representative
Indicates this item is a Medical Device
Indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA) and also found on products sold outside the EEA that have been manufactured to EEA standards