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ClariPulmo

by ClariPi Inc.

Ref ClariPulmo

ClariPulmo is a Class IIa device made by ClariPI Inc., registered in EUDAMED on 22 Dec 2022 (Basic UDI-DI B-88000468PMO-20GUNQ) and cleared under FDA 510(k) K203783 on 6 Apr 2022, 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) K203783↗

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-88000468PMO-20GUNQ Basic UDI-DI D-88000468PMO-20GUNQUDI-DIDate22 Dec 2022RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK203783 Date6 Apr 2022IssuedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-88000468PMO-20GUNQ registered 22 Dec 2022 Active
  • FDA 510(k) K203783 decided 6 Apr 2022 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K203783
  2. Registered EUDAMED B-88000468PMO-20GUNQ

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  • Withdrawn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
ClariPulmo
Primary DI / UDI-DI
D-88000468PMO-20GUNQ
Basic UDI-DI
B-88000468PMO-20GUNQ
EMDN code
Z11030692 Computed tomographs (CT) - medical device software
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Poland

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.

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See all devices from ClariPI Inc. →

Properties

Other properties (12, all answered No)