Identity
- Trade Name
- nordicAudio HeadSet 3T EUDAMEDnordicAudio 3T EUDAMED
- Device Name
- nordicAudio EUDAMED
- Model / Reference
- 1.0 EUDAMED102123 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07090042053068 EUDAMED
- Basic UDI-DI
- 70900420530074 EUDAMED
- Direct Marketing DI
- 07090042053068 EUDAMED
- EMDN Code
- Z11020780 INTEGRATED MRI/PET SYSTEMS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Norway EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
nordicAudio HeadSet 3T by Nordicneurolab AS — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 70900420530074 | Class I | Active |
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Manufacturer
- Manufacturer
- NordicNeuroLab AS
- EUDAMED SRN
- NO-MF-000000555
Sources (2)
- EUDAMED 95db0a7e-998d-419b-9d45-a286cb7302fa 61 fields · synced Jun 18, 2026
- EUDAMED edd3aab6-416c-423c-b63b-9269a7c9fcff 61 fields · synced Jun 18, 2026