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Cardio-HART

by Cardio-Phoenix Inc. 2 variants

Ref CP0000003CTTV65Model V6.5

Active European Union

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/MDD NumberB-++G727CP0000003CTTV65Y2 Basic UDI-DI ++G727CP0000003CTTV65Y2UDI-DIDate22 May 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Cardio-TriTest
Model / Reference
V6.5, CP0000003CTTV65
Primary DI / UDI-DI
++G727CP0000003CTTV65Y2
Basic UDI-DI
B-++G727CP0000003CTTV65Y2
EMDN Code
Z12050302, Z12050303, Z12050392, Z12059012
Device Class
Class IIa
EU market of registration
Cyprus

Manufacturer details

EUDAMED SRN
CA-MF-000046364
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Cardio-Phoenix Inc.

Properties

  • Measuring Function

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No