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inHEART Portal

by inHEART 2 variants

Ref v5

inHEART Portal (v5) is a Class I device made by Inheart, registered in EUDAMED on 29 Jan 2025 (Basic UDI-DI 3770019599Portalv42J), active as of 25 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

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/MDR Number3770019599Portalv42J Basic UDI-DI 03770019599181UDI-DIDate29 Jan 2025RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Model / reference
v5
Primary DI / UDI-DI
03770019599181
Basic UDI-DI
3770019599Portalv42J
EMDN code
Z11069092 Various digital bioimaging management instruments - medical device software
Device class
Class I
Special device type
Software
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000006723

Similar devices in this category

Other devices filed under VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from Inheart

See all devices from Inheart →

Properties

Other properties (14, all answered No)