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1085 ICS Impulse Monocular Ocu. Ltd., Lateral Head Imp, LARP/RALPHead Imp, Mono…
EUDAMEDClass IIa (EU MDR)
Ref 8-04-16217Model 1085 ICS Impulse System
Identity
- Trade Name
- 1085 ICS Impulse Monocular Ocu. Ltd.,Lateral Head Imp,LARP/RALPHead Imp, Mono. Positional EUDAMED
- Device Name
- 1085 ICS Impulse System EUDAMED
- Model / Reference
- 1085 ICS Impulse System EUDAMED8-04-16217 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713315007194 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
1085 ICS Impulse Monocular Ocu. Ltd., Lateral Head Imp, LARP/RALPHead Imp, Mono… by Natus Medical Denmark ApS — Class IIa — MDR — listed in EUDAMED
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 8a13ca9f-e3a8-4f0a-b3fe-14124f156f78 61 fields · synced Jun 18, 2026