Skip to content

Lepu Medical

by Shenzhen Viatom Technology Co., Ltd. 13 variants

Ref EHL-1TModel ER1-LW，ER1-LB

Lepu Medical (EHL-1T) is a Class IIa device made by Shenzhen Viatom Technology Co., Ltd., registered in EUDAMED on 6 Jun 2023 (Basic UDI-DI 69344401ER1-LWER), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69344401ER1-LWER Basic UDI-DI 06934440103691UDI-DIDate6 Jun 2023RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Dynamic ECG Recorder
Model / reference
ER1-LW，ER1-LB, EHL-1T
Primary DI / UDI-DI
06934440103691
Basic UDI-DI
69344401ER1-LWER
Direct marketing DI
06934440103691
EMDN code
Z12050403 ECG holter recorders
Device class
Class IIa
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000012182
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Similar devices in this category

Other devices filed under ECG HOLTER RECORDERS.

Other devices from Viatom Technology Co., Ltd.

See all devices from Viatom Technology Co., Ltd. →

Properties

  • Measuring function
Other properties (13, all answered No)