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1091, ICS Dizcovery Universal Face Cushion (Qty 40)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 045657Model 1091 ICS Dizcovery System
Identity
- Trade Name
- 1091, ICS Dizcovery Universal Face Cushion (Qty 40) EUDAMEDFDA UDI
- Generic Name
- Electronystagmograph FDA UDI
- Device Name
- 1091 ICS Dizcovery System EUDAMED1091, ICS Dizcovery Universal Face Cushion (qty 40) FDA UDI
- Model / Reference
- 1091 ICS Dizcovery System EUDAMED045657 EUDAMEDFDA UDI
- Description
- 1091, ICS Dizcovery Universal Face Cushion (qty 40) FDA UDI
Identifiers
- Catalog Number
- 045657 FDA UDI
- Primary DI / UDI-DI
- 05713315010880 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
Yes
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 Universal Face Cushion (Qty 40) by Natus Medical Denmark ApS — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 a72e48b3-7884-4a72-929d-201f965c8d44 61 fields · synced Jul 28, 2026
- FDA UDI 30cfddbc-2ac5-4321-90b2-e693aa8f7429 34 fields · synced May 30, 2026