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Raycome

by Shenzhen Raycome Health Technology Co., Ltd 9 variants

Ref BP520DBModel BP520D,BP520DB,BP550D,BP550DB,BP550D-H,BP550DB-H

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69541601BPM03KJ Basic UDI-DI 06954160100527UDI-DIDate7 Sep 2026RegisteredStatusActive

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  • Withdrawn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
Pulsewave Blood Pressure Monitor
Model / Reference
BP520D, BP520DB, BP550D, BP550DB, BP550D-H, BP550DB-H
Primary DI / UDI-DI
06954160100527
Basic UDI-DI
69541601BPM03KJ
Direct Marketing DI
06954160100527
EMDN Code
Z1203020302 Non–invasive blood pressure monitoring instruments
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000033181
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shenzhen Raycome Health Technology Co., Ltd

See all devices from Shenzhen Raycome Health 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