ACARIX AS

FDA Device Registration & Listing · Hellerup Hovedstaden, DK · Registration 3019252624

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3019252624
FEI Number
3019252624
Entity Name
ACARIX AS
City/State/Country
Hellerup Hovedstaden, DK
Establishment Address
Ryvangs Alle 81-83, Hellerup Hovedstaden DK-2900, DK
Establishment Type(s)
Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Acarix AS (Owner Number: 10081966)
Owner / Operator Contact Address
Ryvangs Alle 81-83, Hellerup, DK-84 DK-2900, DK
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
DEN190047
PMA Number
N/A

All Registered Proprietary Names

CADScor System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QMW Coronary Artery Disease Risk Indicator From Acoustic Heart Signals Cardiovascular Class 2 870.1420 2021-06-01

Official Correspondent

No official correspondent registered.

US Agent Details

Carma Connely Business: Acarix USA Inc Email: Carma.connely@acarix.com Phone: (949) 6366530

Related Public Records

Same Entity

Acarix AS
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019252624. Last updated year: 2026. Please use registration number 3019252624 when referencing this establishment in official correspondence.
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