FDA.reportPublic FDA data

ACARIX AS

Matched from indexed company URL: Acarix A

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30192526243019252624ACARIX AS1N2026-01-01Ryvangs Alle 81-83 Hellerup Hovedstaden DK DK-2900

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05700002223012Acarix CADScor Patch - Acarix CADScor Patch, 20x patch in box. The intended use of the CADScor System is to record heart sounds, murmurs and vibration for calculation of a patient specific score, indicating the risk of coronary stenosis, as an aid in cardiac analysis and diagnosis.9999999999xx@xx.xx
05700002223029Acarix CADScor Patch - Acarix CADScor Patch, 20x patch in box.The intended use of the CADScor System is to record heart sounds, murmurs and vibration for calculation of a patient specific score, indicating the risk of coronary stenosis, as an aid in cardiac analysis and diagnosis.9999999999xx@xx.xx
05700002223050Acarix CADScor System - CADScor System (ACS-1401), 1x system package. US-FDA version.The intended use of the CADScor System is to record heart sounds, murmurs and vibration for calculation of a patient specific score, indicating the risk of coronary stenosis, as an aid in cardiac analysis and diagnosis.9999999999xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2932561208958947DEN190047CADScor SystemQMW2020-11-24

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QMW12020-11-24

GUDID#