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Organization name
UDI-DI code
Reference / catalog number

Hilo Spot (Aktiia Bracelet G2) — Class IIa MDR by Aktiia SA

MD Atlas
Aktiia SA

EUDAMED last updated this device on Mar 21, 2025

Hilo Spot (Aktiia Bracelet G2)

7649998849AKG2R7

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Aktiia SA
UDI-DI code: 17649998849040
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	Apr 25, 2024	May 14, 2024

Device identification

Trade name: Hilo Spot (Aktiia Bracelet G2)
UDI-DI code: 17649998849040
Basic UDI-DI: 7649998849AKG2R7
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: Hilo Spot is a non-invasive blood pressure (BP) monitor intended to measure optical Photo-plethysmography (PPG) signals on the user’s wrist or fingertip and to calculate blood pressure values using a Pulse Wave Analysis (PWA) technique. Hilo Spot can also calculate heart rate based on the same measurement and analysis technology.
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
Z1203020599NON-INVASIVE BLOOD PRESSURE GAUGES - OTHER

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 Backend7649998849AKBACKENDGHOn the market Hilo Band7649998849AKBraceletYWOn the market Hilo Band (Aktiia Bracelet G1)7649998849AKBraceletYWOn 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.