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CAAS A-Valve 2.1

by Pie Medical Imaging B.V.

Ref 2.1Model CAAS A-Valve

Active European Union and United States. Also listed in GUDID (US).

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) K143044↗

+2 more

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08056304454270 Basic UDI-DI 08056304454270UDI-DIDate18 Aug 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number08056304454270 UDI-DI Date19 May 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK143044 Date6 Feb 2015IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08056304454270 registered 18 Aug 2022 Active
  • FDA 510(k) K143044 decided 6 Feb 2015 Active· +2 more in the status table
  • FDA GUDID UDI-DI 08056304454270 listed 19 May 2020 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K052988
  2. Cleared FDA 510(k) K113076
  3. Cleared FDA 510(k) K143044
  4. Listed FDA GUDID 08056304454270
  5. Registered EUDAMED B-08056304454270

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  • Withdrawn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) · GUDID

Full name
CAAS A-Valve
Generic name
Radiology DICOM image processing application software
Model / reference
CAAS A-Valve, 2.1
Primary DI / UDI-DI
08056304454270
Basic UDI-DI
B-08056304454270
510(k) Number
FDA product code
LLZ
EMDN code
Z11039082 Various radiodiagnostic and interventional instruments - software accessories
GMDN term
Radiology DICOM image processing application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
NL-MF-000001540

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CAAS A-Valve 2.1 is a measuring device (Nomenclature Code: Z11039082) designed for cardiovascular analysis, specifically for assessing aortic valve function and morphology. It provides quantitative measurements to support clinical decision-making in structural heart disease evaluation, including valve area, gradient, and effective orifice area calculations.

This device is supplied as a non-sterile, non-reusable software-based solution for use in clinical or research settings. It operates on compatible imaging platforms and requires no reprocessing or sterilization. The CAAS A-Valve 2.1 is authorized under FDA 510K and MDD compliance, with a Basic UDI of B-08056304454270. It is classified as Class IIa and includes a unique UDI for traceability.

Similar devices in this category

Other devices filed under VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES.

Other devices from Pie Medical Imaging B.V.

See all devices from Pie Medical Imaging B.V. →

Properties

  • Measuring function
  • Prescription use
  • Manufacturing date
Other properties (20, all answered No)