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Hilo App (Aktiia G2C Mobile Application)

EUDAMED

Class IIa (EU MDR)

Ref N/AModel G2C

by Aktiia SA

Identity

Trade Name
Hilo App (Aktiia G2C Mobile Application) EUDAMED
Device Name
Aktiia G2C Mobile Application EUDAMED
Model / Reference
G2C EUDAMED
N/A EUDAMED

Identifiers

Primary DI / UDI-DI
17649998849057 EUDAMED
Basic UDI-DI
7649998849AKG2CAPPRP EUDAMED
Direct Marketing DI
17649998849057 EUDAMED
EMDN Code
Z12030282 VITAL SIGNS MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Special Device Type
Software EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Hilo App (Aktiia G2C Mobile Application) by Aktiia SA — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Aktiia SA
EUDAMED SRN
CH-MF-000015833
Authorised Representative
Veranex Germany GmbH DE-AR-000005578

Sources (1)

  • EUDAMED b491c2ed-12d2-4765-8406-d7226ea66507 61 fields · synced Jul 30, 2026