Om DANBIO
DANBIO SW-version
Version: 1.0.1
Build nr.: 1.0.1.2026.39.7
Medical Device
DANBIO er et medicinsk udstyr (Medical Device)
UDI-DI -- Unique Device Identifier
05700002290908
ZiteLab ApS
Peter Bangsvej 7A
2000 Frederiksberg
Single registration number (SRN): DK-MF-000038975
CE-mærkning
DANBIO bliver CE-mærket som medicinsk udstyr i klasse IIa, som opfylder kravene i Forordning for medicinsk udstyr (EU) 2017/745, også kaldet MDR.
BSI er notified body for processen, kode: 2797
DANBIO er en applikation på ZiteLabPro platformen.
DANBIO er en database, der består af oplysninger, som anvendes til 3 formål:
- Behandling: For at følge udviklingen i din gigt og din behandling
- Forskning: For at gøre behandling af gigt bedre -- nu og i fremtiden
- Kvalitet: For at sikre høj kvalitet i behandlingen af gigt
DANBIO indsamler PRO-data (patient rapporterede outcomes), når patienter besvarer spørgeskemaer i forbindelse med behandlingen.
About DANBIO
DANBIO SW-version
Version: 1.0.1
Build nr.: 1.0.1.2026.39.7
Medical Device
DANBIO is a Medical Device
UDI-DI -- Unique Device Identifier
05700002290908
ZiteLab ApS
Peter Bangsvej 7A
2000 Frederiksberg
Single registration number (SRN): DK-MF-000038975
CE marking
DANBIO will be CE marked as a class IIa medical device, which meets the requirements of the Medical Devices Regulation (EU) 2017/745, also known as MDR.
BSI is notified body of the process, code: 2797
DANBIO is an application on the ZiteLabPro platform
DANBIO is a database consisting of information that is used for 3 purposes:
- Treatment: To follow the development of your arthritis and your treatment
- Research: To improve the treatment of arthritis -- now and in the future
- Quality: To ensure high quality in the treatment of arthritis
DANBIO collects PRO data (patient reported outcomes) when patients answer questionnaires in connection with the treatment.