Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016442138

FEI Number

3016442138

Entity Name

CSD Labs International Inc.

City/State/Country

Ottawa Ontario, CA

Establishment Address

78 George St, Suite 204, Ottawa Ontario K1N 5W1, CA

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

CSD Labs GmbH (Owner Number: 10062365)

Owner / Operator Contact Address

Krenngasse 12, Graz, AT-6 8010, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252284

PMA Number

N/A

All Registered Proprietary Names

eMurmur Heart AI

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQD	Stethoscope, Electronic	Cardiovascular	Class 2	870.1875	2025-12-23
DQC	Phonocardiograph	Cardiovascular	Class 1	870.2390	2025-12-23

Official Correspondent

Andreas Schriefl

US Agent Details

Pasquale Carvelli Business: Cosmereg LLC Email: pasquale.carvelli@cosmereg.com Phone: (727) 3509380

Related Public Records

Same Entity

CSD Labs GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K771506	Swartz Medical Equipment	STETHOSCOPE	1977-08-26
K082528	Noble Anesthesia-Air, Inc.	SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM	2009-03-06

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8010482	RUDOLF RIESTER GMBH	JUNGINGEN Baden-Wurttemberg, DE
3004582233	TEAM PRECISION PUBLIC COMPANY LIMITED	Tanyaburi Pathum Thani, TH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016442138. Last updated year: 2026. Please use registration number 3016442138 when referencing this establishment in official correspondence.