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1091, ICS Dizcovery LCD Panels
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 045652Model 1091 ICS Dizcovery System
Identity
- Trade Name
- 1091, ICS Dizcovery LCD Panels EUDAMEDFDA UDI
- Generic Name
- Electronystagmograph FDA UDI
- Device Name
- 1091 ICS Dizcovery System EUDAMED1091, ICS Dizcovery LCD Panels FDA UDI
- Model / Reference
- 1091 ICS Dizcovery System EUDAMED045652 EUDAMEDFDA UDI
- Description
- 1091, ICS Dizcovery LCD Panels FDA UDI
Identifiers
- Catalog Number
- 045652 FDA UDI
- Primary DI / UDI-DI
- 05713315010828 EUDAMEDFDA UDI
- Basic UDI-DI
- 5713315NA001675V EUDAMED
- FDA Product Code
- GWN FDA UDI
- EMDN Code
- Z12120124 VIDEO/ELECTRONYSTAGMOGRAPHS EUDAMED
- GMDN Term
- Electronystagmograph FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1460 FDA UDI
- Market of Registration
- Denmark 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
1091, ICS Dizcovery LCD Panels by Natus Medical Denmark ApS — Class IIa — 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 | 5713315NA001675V | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (2)
- EUDAMED f62f46d4-4125-41d9-9658-9dcc09431551 61 fields · synced Jul 18, 2026
- FDA UDI b535d6c7-30b7-4581-915d-3cd8d5f0ad5a 34 fields · synced May 30, 2026