Navigation Headrest Universal
EUDAMEDFDA UDIClass I (EU MDR)
by Fiagon GmbH
Identity
- Trade Name
- Navigation Headrest Universal EUDAMEDFDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- Headrest for navigation. Navigation sensor support for image guided surgery. The device is accessory to the Cube 4D Navigation system. FDA UDI
- Model / Reference
- Accessory to Cube4D Navigation System / Navigation sensor support, headrest EUDAMEDE 01 1003 EUDAMEDE011003 FDA UDI
- Description
- Headrest for navigation. Navigation sensor support for image guided surgery. The device is accessory to the Cube 4D Navigation system. FDA UDI
Identifiers
- Catalog Number
- E011003 FDA UDI
- Primary DI / UDI-DI
- 04260759930256 EUDAMEDFDA UDI
- Basic UDI-DI
- 426075993E0026B EUDAMED
- FDA Product Code
- HAW FDA UDIPGW FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Multi-purpose 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 UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Neurological stereotactic surgery system
Navigation Headrest Universal 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
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426075993E0026B | 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 (2)
- EUDAMED 435f8312-793c-4258-89be-4d0ce56508f2 61 fields · synced Jul 14, 2026
- FDA UDI 38160e22-528e-4e5e-8863-1a08117619e9 35 fields · synced May 30, 2026