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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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FibriCheck — 4 UDI-DI variants, MDR (Qompium nv)

MD Atlas
Qompium nv

Data from EUDAMED, last updated May 23, 2026

FibriCheck

54199805893FibriCheckEX

4 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIa

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: Qompium nv

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Device characteristics

Active deviceMeasuring function

Clinical investigations

Registered: No

Identity & classification

Basic UDI-DI: 54199805893FibriCheckEX
Device name: FibriCheck
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Special device type: refdata.special-mdr-device-type.software
Version date: Jul 28, 2025

Manufacturer & authorised representative

Manufacturer

Name: Qompium nv
SRN: BE-MF-000000302
Country: Belgium
Email: jo.vanderauwera@fibricheck.com

Variants by status

UDI-DI variants

4 UDI-DI variants

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Applied filters

basicUdiUlid01K18NH9HTFNMSMZZGXEH5T9RX

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

205419980589309
FibriCheck05419980589347
305419980589316
FibriCheck05419980589323