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Ambulatory Blood Pressure Svstem

by Biomedical Instruments Co., Ltd. China EUDAMED

Ref G5602Model BI5000B EMDN Z12050404

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06970912080350 Basic UDI-DIDate2 Feb 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Ambulatory Blood Pressure Svstem
Model / Reference
BI5000B, G5602
Primary DI / UDI-DI
06970912080350
Basic UDI-DI
B-06970912080350
EMDN Code
Z12050404 Blood pressure holter recorders
Device Class
Class IIa
Market of Registration
Portugal

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 (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED ded0bd99-8189-4981-b526-655a4b91c2f4 61 fields · synced 24 Oct 2026