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Holter Pocket

by Wenzhou Shengkai Technology Industry Co., Ltd. China EUDAMED

Ref HP01Model HP01

EMDN Z12050485

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697307523HolterPocketSC Basic UDI-DIDate3 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Holter Pocket
Model / Reference
HP01
Primary DI / UDI-DI
06973075231201
Basic UDI-DI
697307523HolterPocketSC
EMDN Code
Z12050485 Holter system instruments for cardiovascular parameters - consumables
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000021411
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Wenzhou Shengkai Technology Industry Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 59f5f210-941f-4572-942d-5da75504d1d3 61 fields · synced 22 Oct 2026