Acarix CADScor System

FDA UDI

Class II (US FDA UDI)

by Acarix A/S

Identity

Trade Name: Acarix CADScor System FDA UDI
Generic Name: Phonocardiograph FDA UDI
Device Name: 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. FDA UDI
Model / Reference: ACS-1401 FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: ACS-1401 (1x, US-FDA) FDA UDI
Primary DI / UDI-DI: 05700002223050 FDA UDI
510(k) Number: DEN190047 FDA UDI
FDA Product Code: QMW FDA UDI
GMDN Term: Phonocardiograph FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1420 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Phonocardiograph

Acarix CADScor System by Acarix A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Acarix CADScor Patch — Acarix A/S · Class II

Cleared under the same submission

DEN190047 also covers:

Acarix CADScor Patch — Acarix A/S

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Acarix A/S

Sources (1)

FDA UDI 607646cd-7e5e-4254-bf75-8b127e57d188 37 fields · synced May 30, 2026