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nordicAudio HeadSet 1, 5T
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 102134Model 1.0510(k) K251937
Identity
- Trade Name
- nordicAudio HeadSet 1,5T EUDAMEDnordicAudio 1,5T EUDAMED
- Device Name
- nordicAudio EUDAMED
- Model / Reference
- 1.0 EUDAMED102134 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07090042053112 EUDAMED
- Basic UDI-DI
- 70900420530074 EUDAMED
- Direct Marketing DI
- 07090042053112 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 1, 5T by Nordicneurolab AS — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251937 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 70900420530074 | Class I | Active |
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Manufacturer
- Manufacturer
- NordicNeuroLab AS
- EUDAMED SRN
- NO-MF-000000555
Sources (3)
- EUDAMED 2a1aba77-32b2-4d3c-a873-bb75253acc0d 85 fields · synced Jul 18, 2026
- EUDAMED 0ae674e1-5c60-4abf-9a57-d6a60d65d39a 61 fields · synced Jul 18, 2026
- FDA 510(k) K251937 1 fields · synced May 18, 2026