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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Hilo Backend — Class IIa MDR by Aktiia SA

MD Atlas
Aktiia SA

EUDAMED last updated this device on Mar 12, 2026

Hilo Backend

7649998849AKBACKENDGH

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Aktiia SA
UDI-DI code: 17649998849064
Reference / catalog number: 17649998849064

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Manufacturer information

Organization name: Aktiia SA
SRN: CH-MF-000015833
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jan 1, 2021	Mar 12, 2026

Device identification

Trade name: Hilo Backend
UDI-DI code: 17649998849064
Basic UDI-DI: 7649998849AKBACKENDGH
Reference / catalog number: 17649998849064
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The Hilo Backend is MDSW and operates within the Hilo Spot system and is 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.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12030292VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Hilo App (Aktiia G2C Mobile Application)7649998849AKG2CAPPRPOn the market Hilo Band7649998849AKBraceletYWOn the market Hilo Band (Aktiia Bracelet G1)7649998849AKBraceletYWOn the market Hilo Spot (Aktiia Bracelet G2)7649998849AKG2R7On the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.