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Mtbk-H190(Kd-558BR)

by Andon Health Co., Ltd. China EUDAMED

Ref KD-558BR EMDN Z1203020302

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69302518BPMD05GX Basic UDI-DIDate15 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Arm Blood Pressure Monitor
Model / Reference
KD-558BR
Primary DI / UDI-DI
06930251803584
Basic UDI-DI
69302518BPMD05GX
EMDN Code
Z1203020302 Non–invasive blood pressure monitoring instruments
Device Class
Class IIa
Market of Registration
Portugal

Manufacturer details

EUDAMED SRN
CN-MF-000001799
Authorised representative
iHealthLabs Europe SAS FR-AR-000000340

Other devices from Andon Health Co., Ltd.

See all devices from Andon Health Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED d2e24d00-4c94-4c47-88f8-c636ca052560 61 fields · synced 23 Oct 2026