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vHIT ICS Impulse
EUDAMEDClass IIa (EU MDR)
Ref 8-04-16223Model 1085 ICS Impulse System
Identity
- Trade Name
- vHIT ICS Impulse EUDAMED
- Device Name
- 1085 ICS Impulse System EUDAMED
- Model / Reference
- 1085 ICS Impulse System EUDAMED8-04-16223 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713315008047 EUDAMED
- Basic UDI-DI
- 5713315NA001014X EUDAMED
- EMDN Code
- Z12120124 VIDEO/ELECTRONYSTAGMOGRAPHS 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
vHIT ICS Impulse by Natus Medical Denmark ApS — Class IIa — 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 | 5713315NA001014X | Class IIa | Active |
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Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (1)
- EUDAMED 53e32b9f-5f77-42c3-82c5-42afa05cbca8 61 fields · synced Jul 12, 2026