Identity
- Trade Name
- VisualSystem HD EUDAMEDVisual System HD FDA UDI
- Generic Name
- Visual stimulator FDA UDI
- Device Name
- VisualSystem HD (VSHD) EUDAMEDThe VisualSystem HD allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays (Visual System HD) FDA UDI
- Model / Reference
- 1.2 EUDAMED900005 EUDAMEDVHD-1.2 FDA UDI
- Description
- The VisualSystem HD allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays (Visual System HD) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07090042052108 EUDAMEDFDA UDI
- Basic UDI-DI
- 7090042052006X EUDAMED
- Direct Marketing DI
- 07090042052108 EUDAMED
- 510(k) Number
- K191032 FDA UDI
- FDA Product Code
- LNH FDA UDI
- EMDN Code
- Z11020780 INTEGRATED MRI/PET SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Visual stimulator FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
VisualSystem HD 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 | 7090042052006X | 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 1f3991fd-a65f-426f-b780-ebf698428d30 61 fields · synced May 30, 2026
- FDA UDI efe7572e-9247-4757-aeaa-ade33204a675 34 fields · synced May 30, 2026