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Organization name
UDI-DI code
Reference / catalog number

Hilo Band — Class IIa MDR by Aktiia SA

MD Atlas
Aktiia SA

EUDAMED last updated this device on Mar 12, 2026

Hilo Band

7649998849AKBraceletYW

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Aktiia SA
UDI-DI code: 17649998849088
Reference / catalog number: HILO BPM-004-U (S)-G1

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Manufacturer information

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

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW011
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Mar 1, 2025	Still on market

Device identification

Trade name: Hilo Band
UDI-DI code: 17649998849088
Basic UDI-DI: 7649998849AKBraceletYW
Reference / catalog number: HILO BPM-004-U (S)-G1
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 Band of Hilo Blood Pressure Monitor
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z1203020599NON-INVASIVE BLOOD PRESSURE GAUGES - OTHER
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 App (Aktiia G2C Mobile Application)7649998849AKG2CAPPRPOn the market Hilo Backend7649998849AKBACKENDGHOn 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.