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BPBIO320n

by InBody Co., Ltd. 3 variants

Ref E4Model BPBIO320

Active European Union

CE MDR

Valid until

9 Aug 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberKR23/00000132 Date3 Jun 2024IssuedStatusActive EUDAMED: not on the EU market expires 9 Aug 2028

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • KR23/00000132 Active Supplemented

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    3 Jun 2024
    Expires
    9 Aug 2028
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Blood Pressure Monitor
Model / Reference
BPBIO320, E4
Primary DI / UDI-DI
08809209591157
Basic UDI-DI
880920959F2YB
Direct Marketing DI
08809209591157
EMDN Code
Z1203020501 Non–invasive oscillometric blood pressure gauges
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
KR-MF-000011833
Authorised representative
InBody Europe B.V. NL-AR-000011789

Other devices from InBody Co., Ltd.

See all devices from InBody 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