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Pulse Wave arrhythmia analysis

by Huawei Device Co., Ltd.

Ref PPG-1

Active European Union

CE MDR

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number694210319456245J9 Basic UDI-DI 06942103169946UDI-DIDate28 Aug 2025RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Pulse Wave A-fib Prompt App
Model / Reference
PPG-1
Primary DI / UDI-DI
06942103169946
Basic UDI-DI
694210319456245J9
Direct Marketing DI
06942103169946
EMDN Code
Z12050392 Electrocardiographs - medical device software
Device Class
Class IIa
Special Device Type
Software
EU market of registration
Cyprus

Manufacturer details

EUDAMED SRN
CN-MF-000022811
Authorised representative
Lotus NL B.V. NL-AR-000000121

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See all devices from Huawei Device Co., Ltd. →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No