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VirtuEye
EUDAMEDFDA UDIClass I (EU MDR)
Ref E 01 1430Model Accessory to Cube4D Navigation system / registration device, non-tactile
by Fiagon GmbH
Identity
- Trade Name
- VirtuEye EUDAMEDFDA UDI
- Generic Name
- ENT stereotactic surgery system FDA UDI
- Device Name
- The device VirtuEye is a device for non-tactile registration for image guided surgical procedures. The device is accessory to the Cube 4D Navigation system. FDA UDIAccessory to Cube navigation systems. Device for registration. FDA UDI
- Model / Reference
- Accessory to Cube4D Navigation system / registration device, non-tactile EUDAMEDE 01 1430 EUDAMEDE011430 FDA UDIv2 FDA UDI
- Description
- The device VirtuEye is a device for non-tactile registration for image guided surgical procedures. The device is accessory to the Cube 4D Navigation system. FDA UDIAccessory to Cube navigation systems. Device for registration. FDA UDI
Identifiers
- Catalog Number
- E011430 FDA UDIE 01 1430 FDA UDI
- Primary DI / UDI-DI
- 04260759930126 EUDAMEDFDA UDIEFIAE0114301 FDA UDI
- Basic UDI-DI
- 426075993E0046F EUDAMED
- Direct Marketing DI
- 04260759930126 EUDAMED
- 510(k) Number
- K211291 FDA UDI
- FDA Product Code
- PGW FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- ENT stereotactic surgery system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDINot 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Neurological stereotactic surgery system
VirtuEye by Fiagon GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 426075993E0046F | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fiagon GmbH
- EUDAMED SRN
- DE-MF-000010763
Sources (3)
- EUDAMED ad5faad9-7812-430c-98b6-1a55c18fc5c6 61 fields · synced Jul 30, 2026
- FDA UDI e9cbdd06-bb57-4871-944c-da91ee404a5b 35 fields · synced May 29, 2026
- FDA UDI 1880c865-60c5-4a6d-88d7-fa7607c14966 36 fields · synced May 30, 2026