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Easy ECG Monitor

by Shenzhen Creative Industry Co., Ltd. 3 variants

Ref H600Model PC-80D、H600

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69419006PC80D01CV Basic UDI-DI 06941900606692UDI-DIDate16 May 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Easy ECG Monitor
Model / Reference
PC-80D、H600, H600
Primary DI / UDI-DI
06941900606692
Basic UDI-DI
69419006PC80D01CV
Direct Marketing DI
06941900606692
EMDN Code
Z12050301 General purpose electrocardiographs
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000009430
Authorised representative
Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551

From the manufacturer

Manufacturer's product page: Lepu PC-80B Portable ECG Monitor Easy EKG Machine Handheld Heart Rate Monitor

Other devices from Shenzhen Creative Industry Co., Ltd.

See all devices from Shenzhen Creative Industry Co., Ltd. →

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No