Identity
- Trade Name
- nordicBrainEx EUDAMED
- Device Name
- nordicBrainEx EUDAMED
- Model / Reference
- 2.3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-nordicBrainExSY EUDAMED
- Basic UDI-DI
- B-nordicBrainExSY EUDAMED
- EMDN Code
- Z11020792 INTEGRATED MRI/PET SYSTEMS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Norway EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
nordicBrainEx by Nordicneurolab AS — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K133910 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K163324 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-nordicBrainExSY | Class IIa | Active |
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Manufacturer
- Manufacturer
- NordicNeuroLab AS
- EUDAMED SRN
- NO-MF-000000555
Sources (3)
- EUDAMED 40c4ddef-8347-46cf-bc4a-e73e01793ca1 61 fields · synced Jul 29, 2026
- EUDAMED a13e450f-7389-4878-bbc0-aecd8f8cebf9 61 fields · synced Jul 29, 2026
- FDA 510(k) K133910 1 fields · synced May 18, 2026