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Heart Failure Analysis solution

by Implicity

Ref IM005

Heart Failure Analysis solution (IM005) is a Class I device made by Implicity, registered in EUDAMED on 22 Feb 2022 (Basic UDI-DI B-IM005U4), withdrawn as of 25 Oct 2026.

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-IM005U4 Basic UDI-DI D-IM005U4UDI-DIDate22 Feb 2022RegisteredStatusWithdrawn No longer placed on the EU market

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Withdrawn

Specification

EUDAMED

Device name
Heart Failure Analysis solution
Model / reference
IM005
Primary DI / UDI-DI
D-IM005U4
Basic UDI-DI
B-IM005U4
EMDN code
Z12040182 General medicine diagnosis and monitoring instruments - software accessories
Device class
Class I
EU registration type
Legacy device (under a directive)
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000014184

Similar devices in this category

Other devices filed under GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES.

Other devices from Implicity

Properties

Other properties (12, all answered No)