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autonomie et bien être Upper Arm Electronic Blood Pressure Monitor

by Shenzhen Urion Technology Co., Ltd.

Ref U80HModel U80CH series, 80H series, U80M series, U80NH series, U81X series, U81RH series, U83Z series, U86E series, U90E series Total: 69 models

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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 Number69538259UBP8K Basic UDI-DI 06953825911195UDI-DIDate16 Aug 2023RegisteredStatusActive

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.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Upper Arm Electronic Blood Pressure Monitor
Model / Reference
U80CH series, 80H series, U80M series, U80NH series, U81X series, U81RH series, U83Z series, U86E series, U90E series Total: 69 models, U80H
Primary DI / UDI-DI
06953825911195
Basic UDI-DI
69538259UBP8K
Direct Marketing DI
06953825911195
EMDN Code
Z1203020501 Non–invasive oscillometric blood pressure gauges
Device Class
Class IIa
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000018740
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Shenzhen Urion Technology Co., Ltd

See all devices from Shenzhen Urion Technology 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