Identity
- Trade Name
- ResponseGrips EUDAMEDFDA UDI
- Generic Name
- Interactive-evaluation stimulus-response patient trigger FDA UDI
- Device Name
- ResponseGrip EUDAMEDThe ResponseGrip is an MRI-safe patient response device, providing real-time feedback of a patient response. The ResponseGrip consists of two hand-held grips with two buttons each. By pressing the buttons the patient can respond to the presented stimulus. The ResponseGrip is connected to an optical-electrical adapter which converts light to electrical signals. The electrical signal is fed to the Stimulus PC by using standard PC communication interfaces. FDA UDI
- Model / Reference
- 4.0 EUDAMEDFDA UDI
- Description
- The ResponseGrip is an MRI-safe patient response device, providing real-time feedback of a patient response. The ResponseGrip consists of two hand-held grips with two buttons each. By pressing the buttons the patient can respond to the presented stimulus. The ResponseGrip is connected to an optical-electrical adapter which converts light to electrical signals. The electrical signal is fed to the Stimulus PC by using standard PC communication interfaces. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07090042054010 EUDAMEDFDA UDI
- Basic UDI-DI
- 7090042054207F EUDAMED
- Direct Marketing DI
- 07090042054010 EUDAMED
- 510(k) Number
- K092253 FDA UDI
- FDA Product Code
- LNH FDA UDI
- EMDN Code
- Z11020780 INTEGRATED MRI/PET SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Interactive-evaluation stimulus-response patient trigger 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 Safe FDA UDI
ResponseGrips 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 | 7090042054207F | 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 60def377-c703-497e-848a-28591f3a7f90 61 fields · synced Jun 19, 2026
- FDA UDI 1f407c5e-995b-43a3-b712-038aa6fb8d0d 35 fields · synced May 30, 2026