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Wrist Blood Pressure Monitor

by Andon Health Co., Ltd. 3 variants

Ref BPW-5 TRANSPORT BOX, BPW-5, KD-722 TRANSPORT BOX, Wrist Blood Pressure Monitor, /Model KD-738BR

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K210768↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69302518BPWD01JV Basic UDI-DI Date16 May 2023RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK210768 Date30 Jul 2021IssuedStatusActive

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 24 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Trade Name
Wrist Blood Pressure Monitor
Kd-738BR(Kd-738BR)
Model / Reference
BPW-5 TRANSPORT BOX, BPW-5, KD-722 TRANSPORT BOX, KD-738BR, Wrist Blood Pressure Monitor, /
Primary DI / UDI-DI
83615371700249, 03615371700243, 06930251802334, 06930251873846, 06930251802341, 06930251803256
Basic UDI-DI
69302518BPWD01JV, 69302518BPWD02JX, B-06930251873846
Direct Marketing DI
06930251820062
06930251803256
EMDN Code
W05020102, Z1203020302
Device Class
Class IIa
EU market of registration
France
Germany
Spain

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

  • 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