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VirtuEye Pro
EUDAMEDClass I (EU MDR)
Ref E 10 1440Model Accessory to Cube4D Navigation system / registration device, non-tactile
by Fiagon GmbH
Identity
- Trade Name
- VirtuEye Pro EUDAMED
- Model / Reference
- Accessory to Cube4D Navigation system / registration device, non-tactile EUDAMEDE 10 1440 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260759931697 EUDAMED
- Basic UDI-DI
- 426075993E0046F EUDAMED
- Direct Marketing DI
- 04260759931697 EUDAMED
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Neurological stereotactic surgery system
VirtuEye Pro by Fiagon GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426075993E0046F | Class I | Active |
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Manufacturer
- Manufacturer
- Fiagon GmbH
- EUDAMED SRN
- DE-MF-000010763
Sources (1)
- EUDAMED 2bdb47ed-1ead-4641-92b5-c11ca50f0a35 61 fields · synced Jun 19, 2026