Skip to content

Wearable ECG Sensor

by Biomedical Instruments Co., Ltd. China EUDAMED

Ref PS-B3FModel PS-B3A, PS-B3B, PS-B3C, PS-B3D, PS-B3E, PS-B3F

EMDN Z12050485

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697091208PS2G Basic UDI-DIDate16 Jun 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

Model / Reference
PS-B3A, PS-B3B, PS-B3C, PS-B3D, PS-B3E, PS-B3F
Primary DI / UDI-DI
06970912081326
Basic UDI-DI
697091208PS2G
EMDN Code
Z12050485 Holter system instruments for cardiovascular parameters - consumables
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000016483
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Biomedical Instruments Co., Ltd.

See all devices from Biomedical Instruments 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 37743287-079a-4cdd-8109-cd7becd2c4c7 61 fields · synced 22 Oct 2026