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ICS Impulse - Synchrontized Room Video
EUDAMEDClass IIa (EU MDR)
Ref 8-04-15611Model 1085 ICS Impulse System
Identity
- Trade Name
- ICS Impulse (Full w/o webcam Hardware - Lateral/LARP/RALP/Synchrontized Room Video) EUDAMED
- Device Name
- 1085 ICS Impulse System EUDAMED
- Model / Reference
- 1085 ICS Impulse System EUDAMED8-04-15611 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713315007125 EUDAMED
- Basic UDI-DI
- 5713315NA001014X EUDAMED
- EMDN Code
- Z12120124 VIDEO/ELECTRONYSTAGMOGRAPHS EUDAMED
- Models / Variants
- Full w EUDAMEDo webcam Hardware - Lateral EUDAMEDLARP EUDAMEDRALP EUDAMEDSynchrontized Room Video EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark 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
ICS Impulse - Synchrontized Room Video by Natus Medical Denmark ApS — Class IIa — MDR — listed in EUDAMED — 5 models — 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 | 5713315NA001014X | Class IIa | Active |
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Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (1)
- EUDAMED 288fb6dd-d233-42b3-997a-be6bad65da7d 61 fields · synced Jul 17, 2026