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1091 ICS Dizcovery
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 8-04-16400Model 1091 ICS Dizcovery System
Identity
- Trade Name
- 1091 ICS Dizcovery EUDAMED1091, ICS Dizcovery System FDA UDI
- Generic Name
- Electronystagmograph FDA UDI
- Device Name
- 1091 ICS Dizcovery System EUDAMED1091, ICS Dizcovery System FDA UDI
- Model / Reference
- 1091 ICS Dizcovery System EUDAMED8-04-16400 EUDAMEDFDA UDI
- Description
- 1091, ICS Dizcovery System FDA UDI
Identifiers
- Catalog Number
- 8-04-16400 FDA UDI
- Primary DI / UDI-DI
- 05713315010736 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 by Natus Medical Denmark ApS — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242198 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 5713315NA001675V | Class IIa | Active |
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Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (3)
- EUDAMED 8f572752-d2f6-4a9b-bca0-2b2504ce46f2 61 fields · synced Jul 9, 2026
- FDA UDI bf28cd87-64fa-43cb-9ac4-8fac90da8969 34 fields · synced May 30, 2026
- FDA 510(k) K242198 1 fields · synced May 18, 2026