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Automatic Upper Arm Blood Pressure Monitor

by Cofoe Medical Technology Co., Ltd. 4 variants

Ref KF-65A, KF0101Model KF-65A、KF-65B、KF-65D、KF-65K、KF-65R

Active European Union

CE MDR CE MDD

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/MDD Number69507155BSXYJV2 Basic UDI-DI 06950715500156UDI-DIDate25 Feb 2025RegisteredStatusActive
European UnionCE/MDR Number69507155BSXYJV2 Basic UDI-DI 06950715500156UDI-DIDate25 Feb 2025RegisteredStatusActive

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  • Withdrawn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/MDD, CE/MDR Active

Specification

EUDAMED

Model / Reference
KF-65A、KF-65B、KF-65D、KF-65K、KF-65R, KF-65A, KF0101
Primary DI / UDI-DI
06950715500156
Basic UDI-DI
69507155BSXYJV2, B-06950715500156
EMDN Code
Z1203020501, V0399
Device Class
Class IIa
EU market of registration
Netherlands
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000001077
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Cofoe Medical Technology Co., Ltd.

See all devices from Cofoe Medical 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