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Arm Blood Pressure Monitor

by Andon Health Co., Ltd. 5 variants

Ref KD-5923, /510(k) K222869

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K222869↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number69302518BPMD04GV Basic UDI-DI Date8 Sep 2023RegisteredStatusActive
European UnionCE/MDR EUDAMED Number69302518BPMD04GV Basic UDI-DI Date8 Sep 2023RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Abbreviated NumberK222869 Date15 Feb 2023ClearedStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Trade Name
Arm Blood Pressure Monitor
Kd-5923(Kd-5923)
Model / Reference
KD-5923, /
Primary DI / UDI-DI
06930251820130, 06930251803041, 06930251803249, 06930251803232, 06930251803201
Basic UDI-DI
69302518BPMD04GV, B-06930251820130
Direct Marketing DI
06930251803249
EMDN Code
Z1203020302 Non–invasive blood pressure monitoring instruments
Device Class
Class IIa
EU market of registration
France
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000001799
FDA applicant
Andon Health Co, Ltd.
Authorised representative
iHealthLabs Europe SAS FR-AR-000000340

Other devices from Andon Health Co., Ltd.

See all devices from Andon Health 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