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Organization name
UDI-DI code
Reference / catalog number

Hilo App (Aktiia G2C Mobile… — Class IIa MDR by Aktiia SA

MD Atlas
Aktiia SA

EUDAMED last updated this device on Mar 21, 2025

Hilo App (Aktiia G2C Mobile Application)

7649998849AKG2CAPPRP

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Aktiia SA
UDI-DI code: 17649998849057
Reference / catalog number: N/A

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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	Sep 20, 2024	Still on market

Device identification

Trade name: Hilo App (Aktiia G2C Mobile Application)
UDI-DI code: 17649998849057
Basic UDI-DI: 7649998849AKG2CAPPRP
Reference / catalog number: N/A
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12030282VITAL SIGNS MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES

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 Backend7649998849AKBACKENDGHOn 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.