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Wearable ECG & Arrhythmia diagnosis and monitor

by MEZOO Co., Ltd.

Ref HiCardi+ SmartPatchModel HiCardi+

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800098100246 Basic UDI-DI 08800098100246UDI-DIDate23 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Wearable ECG & Arrhythmia diagnosis and monitor
Model / Reference
HiCardi+, HiCardi+ SmartPatch
Primary DI / UDI-DI
08800098100246
Basic UDI-DI
B-08800098100246
EMDN Code
Z12030201, Z1203020202, Z12050402
Device Class
Class IIb
EU market of registration
Estonia

Manufacturer details

EUDAMED SRN
KR-MF-000039441
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from MEZOO Co., Ltd.

  • HiCardi+ H100

    Class II

Properties

  • Measuring Function

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No