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Holter Recorder

by Shenzhen Carewell EIectronics Co., Ltd. 2 variants

Ref TH12

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06971049341277 Basic UDI-DI 06971049341277UDI-DIDate24 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Holter Recorder
Model / Reference
TH12
Primary DI / UDI-DI
06971049341277
Basic UDI-DI
B-06971049341277
EMDN Code
Z12050403 ECG holter recorders
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000026800
Authorised representative
Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551

Other devices from Shenzhen Carewell EIectronics Co., Ltd.

See all devices from Shenzhen Carewell EIectronics Co., Ltd. →

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