QOMPIUM NV

FDA Device Registration & Listing · Hasselt Limburg, BE · Registration 3015976873

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
3015976873
FEI Number
3015976873
Entity Name
QOMPIUM NV
City/State/Country
Hasselt Limburg, BE
Establishment Address
Kempische Steenweg 303/27, Hasselt Limburg 3500, BE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Qompium NV (Owner Number: 10061438)
Owner / Operator Contact Address
Kempische Steenweg 303/27, Hasselt, BE-VLI 3500, BE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K232804
PMA Number
N/A

All Registered Proprietary Names

FibriCheck

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QME Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate Cardiovascular Class 2 870.2785 2024-07-26
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2024-07-26

Official Correspondent

No official correspondent registered.

US Agent Details

Mindy McCann Business: VP US Operations Qserve Group US Email: usagent@Qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

Qompium NV
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
K820986 Dart Medical Equipment EKG MONITORS, VARIOUS MODELS 1982-04-29
K910450 Medtech Industries, Inc. CARD GUARD-3000 ECG TELEPHONE ADAPTER 1991-05-07
K761318 Cambridge Instruments, Inc. 3038 OPTION B-COMPUT. TRANS. TERMINAL 1977-01-06
K972649 Reynolds Medical , Ltd. CARDIOCALL CARDIAC EVENT RECORDER 1997-12-04
K033410 Remote Diagnostic Technologies , Ltd. TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 2004-03-05

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015976873. Last updated year: 2026. Please use registration number 3015976873 when referencing this establishment in official correspondence.
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