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M2 Comfort (HEM-7188-FLD6)

by OMRON Healthcare Co., Ltd. EUDAMED

Active European Union

Ref HEM-7188-FLD6

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4015672114645K Basic UDI-DIDate3 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Model / Reference
HEM-7188-FLD6
Primary DI / UDI-DI
04015672114647
Basic UDI-DI
4015672114645K
EMDN Code
Z1203020302 Non–invasive blood pressure monitoring instruments
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
JP-MF-000007213
Authorised representative
OMRON Healthcare Europe B.V. NL-AR-000002683

Other devices from OMRON Healthcare Co., Ltd.

See all devices from OMRON Healthcare Co., Ltd. →

Properties

  • 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