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1085 Face Cushion (10 Boxes/120 Cushions)
EUDAMEDClass IIa (EU MDR)
Ref 8-62-50200Model 1085 ICS Impulse System
Identity
- Trade Name
- 1085 Face Cushion (10 Boxes/120 Cushions) EUDAMED
- Device Name
- 1085 ICS Impulse System EUDAMED
- Model / Reference
- 1085 ICS Impulse System EUDAMED8-62-50200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713315008498 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 Face Cushion (10 Boxes/120 Cushions) 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 ede913fd-8abc-41b6-8350-7ea3c7e2d4c2 61 fields · synced Jun 18, 2026