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icompanion

by icometrix

Ref 2.2.z, 2.1.z

icompanion (2.2.z) is a medical device (EU MDR Class IIa; EMDN category medical device software - not included in other classes) made by icometrix NV, registered in EUDAMED on 8 Feb 2024 (Basic UDI-DI ++B621ICOMPANION24F) with CE/MDR certificate BE23/00000345 valid until 11 Dec 2028, active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

11 Dec 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++B621ICOMPANION24F Basic UDI-DI Date8 Feb 2024RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • BE23/00000345 Active Supplemented

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    11 Dec 2023
    Expires
    11 Dec 2028
    Reason
    Change approved

Timeline

3 dated events

  1. Certificate issued EUDAMED BE23/00000345
  2. Registered EUDAMED ++B621ICOMPANION24F
  3. Certificate expires EUDAMED BE23/00000345

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
2.2.z, 2.1.z
Primary DI / UDI-DI
+B621ICOMPANION2X2Y0, +B621ICOMPANION2X1Y0
Basic UDI-DI
++B621ICOMPANION24F
Direct marketing DI
+B621ICOMPANION2X2Y0
+B621ICOMPANION2X1Y0
EMDN code
V92 Medical device software - not included in other classes
Device class
Class IIa
Special device type
Software
EU registration type
Standard device
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000006329

Similar devices in this category

Other devices filed under MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES.

Other devices from icometrix NV

See all devices from icometrix NV →

Properties

Other properties (14, all answered No)