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Holter ECG Workstation

by BORSAM Biomedical Instruments Co., Ltd. China EUDAMED

Ref BS6940-3, iTengo, BS6930-3, BS6940-12

EMDN Z12050403

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06934666200136 Basic UDI-DIDate24 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
BS6940-3, iTengo, BS6930-3, BS6940-12
Primary DI / UDI-DI
06934666200136, 06934666200037, 06934666200006, 06934666200143
Basic UDI-DI
B-06934666200136, B-06934666200037, B-06934666200006, B-06934666200143
EMDN Code
Z12050403 ECG holter recorders
Device Class
Class IIa
Market of Registration
Austria
Hungary
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000023994
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from BORSAM Biomedical Instruments Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (4)

  • EUDAMED 0c7a0054-690b-47dc-96bf-bcd16799c057 61 fields · synced 22 Oct 2026
  • EUDAMED 06934666200037|B-06934666200037 61 fields · synced 18 May 2026
  • EUDAMED 06934666200006|B-06934666200006 61 fields · synced 18 May 2026
  • EUDAMED 06934666200143|B-06934666200143 61 fields · synced 19 May 2026