Skip to content

Blood Pressure Monitor

by Cofoe Medical Technology Co., Ltd.

Ref KF-65A, KF-75C, KF-65BModel KF-65A、KF-65B、KF-65D、KF-65K、KF-65R

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 Number69507155BSXYJV2 Basic UDI-DI Date25 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Automatic Upper Arm Blood Pressure Monitor
Automatic Wrist Blood Pressure Monitor
Model / Reference
KF-65A、KF-65B、KF-65D、KF-65K、KF-65R, KF-65A, KF-75C, KF-65B
Primary DI / UDI-DI
06950715508145, 06950715508169, 06950715508398
Basic UDI-DI
69507155BSXYJV2, 69507155WSXYJ4C
EMDN Code
Z1203020501, Z1203020302
Device Class
Class IIa
EU market of registration
Türkiye
Spain

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