Skip to content

Automatic Upper Arm Blood Pressure Monitor

by Cofoe Medical Technology Co., Ltd. 4 variants

Ref KF0103Model KF-65D, 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-06950715500170 Basic UDI-DI Date13 May 2022RegisteredStatusActive
European UnionCE/MDD NumberB-06950715500170 Basic UDI-DI Date13 May 2022RegisteredStatusActive

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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Trade Name
Automatic Upper Arm Blood Pressure Monitor
KLMED Automatic Upper Arm Blood Pressure Monitor
Model / Reference
KF-65D, KF0103, KF-65A、KF-65B、KF-65D、KF-65K、KF-65R
Primary DI / UDI-DI
06950715500170, 06950715563205
Basic UDI-DI
B-06950715500170, 69507155BSXYJV2
EMDN Code
V0399, Z1203020501
Device Class
Class IIa
EU market of registration
Poland
Netherlands
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