Identity
- Trade Name
- nordicAktiva EUDAMEDFDA UDI
- Generic Name
- MRI system application software FDA UDI
- Device Name
- nordicAktiva EUDAMEDNordicNeuroLab’s nordicAktiva is a stimulus presentation and workflow software which controls the presentation of stimuli during fMRI exams and has been designed specifically with the clinical user in mind. With an intuitive interface and detailed, easy-to-follow instructions, the user is guided step-by-step through the process of presenting stimuli during MR image acquisition. nordicAktiva runs on the stimulus presentation PC to which the NNL fMRI Hardware System is connected. Through the latter audiovisual stimuli are presented to, and feedback is collected from the patient. FDA UDI
- Model / Reference
- 2.0 EUDAMEDFDA UDI
- Description
- NordicNeuroLab’s nordicAktiva is a stimulus presentation and workflow software which controls the presentation of stimuli during fMRI exams and has been designed specifically with the clinical user in mind. With an intuitive interface and detailed, easy-to-follow instructions, the user is guided step-by-step through the process of presenting stimuli during MR image acquisition. nordicAktiva runs on the stimulus presentation PC to which the NNL fMRI Hardware System is connected. Through the latter audiovisual stimuli are presented to, and feedback is collected from the patient. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07090042059060 EUDAMEDFDA UDI
- Basic UDI-DI
- 7090042059218A EUDAMED
- Direct Marketing DI
- 07090042059060 EUDAMED
- 510(k) Number
- K232680 FDA UDI
- FDA Product Code
- LNH FDA UDI
- EMDN Code
- Z11020782 INTEGRATED MRI/PET SYSTEMS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- MRI system application software FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Norway EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
nordicAktiva by Nordicneurolab AS — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7090042059218A | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- NordicNeuroLab AS
- EUDAMED SRN
- NO-MF-000000555
Sources (2)
- EUDAMED 59c53188-3692-43d8-89f6-736741d9738e 61 fields · synced Jul 11, 2026
- FDA UDI f832cc89-4645-4ae8-8433-953809663fd2 35 fields · synced May 30, 2026