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1085, ICS Impulse Vision Denied Solution 2 Kit (50 pcs)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 041481
Identity
- Trade Name
- 1085, ICS Impulse Vision Denied Solution 2 Kit (50 pcs) EUDAMEDICS Impulse Vision Denied Solution 2 Kit (50 pcs) FDA UDI
- Generic Name
- Electronystagmograph FDA UDI
- Device Name
- 1085 ICS Impulse Vision Denied Solution 2 Kit (50 pcs) EUDAMED1085 ICS Impulse Vision Denied Solution 2 Kit (50 pcs) FDA UDI
- Model / Reference
- 041481 EUDAMEDFDA UDI
- Description
- 1085 ICS Impulse Vision Denied Solution 2 Kit (50 pcs) FDA UDI
Identifiers
- Catalog Number
- 041481 FDA UDI
- Primary DI / UDI-DI
- 05713315009983 EUDAMEDFDA UDI
- Basic UDI-DI
- 5713315NA001505C EUDAMED
- FDA Product Code
- GWN FDA UDI
- EMDN Code
- Z12120124 VIDEO/ELECTRONYSTAGMOGRAPHS EUDAMED
- GMDN Term
- Electronystagmograph FDA UDI
Classification
- Device Class
- Class I 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
1085, ICS Impulse Vision Denied Solution 2 Kit (50 pcs) by Natus Medical Denmark ApS — Class I — 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 | 5713315NA001505C | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (2)
- EUDAMED f172e363-b517-4a67-bfd9-70286224baa4 61 fields · synced Jun 19, 2026
- FDA UDI 2d2ea3eb-ba23-46ce-8212-72dbb5fc9500 34 fields · synced May 30, 2026