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Electronic sphygmomanometer

by Wenzhou Bokang Instruments Co., Ltd 7 variants

Ref BK1018Model BK1016, BK1018, BK1016B, BK1016T, BK6002, BK6022, BK6032

Active European Union

CE MDR

Valid until

1 Jul 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6127621CE01 Date29 Nov 2024IssuedStatusActive expires 1 Jul 2028

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 6127621CE01 Active Amended

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    29 Nov 2024
    Expires
    1 Jul 2028
    Reason
    Mnf ar change

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
BK1016, BK1018, BK1016B, BK1016T, BK6002, BK6022, BK6032
Primary DI / UDI-DI
06931038610906
Basic UDI-DI
69310386ELC001C7
EMDN Code
C9006 Aneroid sphygmomanometers
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000021505
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Wenzhou Bokang Instruments Co., Ltd

See all devices from Wenzhou Bokang Instruments 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