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ClariSIGMAM

by ClariPi Inc.

Ref ClariSIGMAM

ClariSIGMAM is a Class I device made by ClariPI Inc., registered in EUDAMED on 22 Dec 2022 (Basic UDI-DI B-88000468SMM-13HQPS) and cleared under FDA 510(k) K203785 on 10 Sep 2021, active as of 24 Oct 2026.

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K203785↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-88000468SMM-13HQPS Basic UDI-DI D-88000468SMM-13HQPSUDI-DIDate22 Dec 2022RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK203785 Date10 Sep 2021IssuedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-88000468SMM-13HQPS registered 22 Dec 2022 Active
  • FDA 510(k) K203785 decided 10 Sep 2021 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K203785
  2. Registered EUDAMED B-88000468SMM-13HQPS

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Active

Specification

EUDAMED · 510(k)

Model / reference
ClariSIGMAM
Primary DI / UDI-DI
D-88000468SMM-13HQPS
Basic UDI-DI
B-88000468SMM-13HQPS
EMDN code
Z11030692 Computed tomographs (CT) - medical device software
Device class
Class I
EU registration type
Legacy device (under a directive)
EU market of registration
Hungary

Manufacturer details

EUDAMED SRN
KR-MF-000031518
Authorised representative
AR Experts B.V. NL-AR-000023989

Similar devices in this category

Other devices filed under COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE.

Other devices from ClariPI Inc.

  • ClariCT.AI 1.3.3

    Class II

  • ClariCT.AI 1.1.0

    Class II

  • ClariCT.AI ClariPET-CT

    Class II

  • ClariSIGMAM 1.1.7

    Class II

See all devices from ClariPI Inc. →

Properties

Other properties (12, all answered No)