Qaelum NV
Active in EUDAMEDBelgiumfrom SRN EUDAMED SRN BE-MF-000021567
- Devices
- 1
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Qaelum NV makes
Qaelum NV develops software designed to monitor and evaluate patient radiation doses in radiology procedures, ensuring precise tracking and optimization of exposure levels. The solution integrates with clinical workflows to provide real-time dose assessments and enhance patient safety during imaging and treatment.
The company’s software is classified as Class IIb under EU medical device regulations and is registered in the EUDAMED database. Qaelum NV operates from Belgium, adhering to EU regulatory requirements for software-as-a-medical-device (SaMD) compliance.
Catalogue
- CE MDR EUDAMED
Company details
- EUDAMED SRN
- BE-MF-000021567
- EU VAT number
- BE 0840 884 387
- EUDAMED status
- Active
- EUDAMED registered name
- Qaelum NV
- Registered address
- 1B, Kolonel Begaultlaan, 3012, Wilsele, Belgium
- Website
- www.qaelum.com
- linkedin.com/company/qaelum
- facebook.com/qaelum
- [email protected]
- Phone
- +32 16 50 27 37
- PRRC contact
- Jeroen Baeck
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 26 Jun 2029
Notified body 1639 1 certificate
- BE24/00000171 Issued
Quality management system EU MDR
- Issued
- 29 Jul 2024
- Expires
- 26 Jun 2029
From the company website
Solution that Monitors, Evaluates and Optimizes the Radiation Dose for Patients. Personalized Software that Maintains Patient Safety in Radiology.
Frequently asked questions
How many devices does Qaelum NV have in the registry?
The registry currently lists 1 device for Qaelum NV. Devices recorded under merged duplicate company entries are counted once.
Which registries list Qaelum NV's devices?
Among its 1 most recently registered device, Qaelum NV has devices listed in EUDAMED (1 device).
What risk classes do Qaelum NV's devices fall under?
Among its 1 most recently registered device, the classes recorded for Qaelum NV's devices are Class IIb. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Qaelum NV?
EUDAMED lists 1 certificate for Qaelum NV (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2024-07-29.
What are the newest devices from Qaelum NV in the registry?
The most recently registered devices listed for Qaelum NV include DOSE-Patient radiation dose monitoring software.