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Navigation Unit Cube4D
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref E 01 1106-HD/8Model Cube 4D Navigation System
by Fiagon GmbH
Identity
- Trade Name
- Navigation Unit Cube4D EUDAMEDFDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- Navigation unit, Component of Cube4D Navigation System FDA UDI
- Model / Reference
- Cube 4D Navigation System EUDAMEDE 01 1106-HD/8 EUDAMEDE011106-HD/8 FDA UDI
- Description
- Navigation unit, Component of Cube4D Navigation System FDA UDI
Identifiers
- Catalog Number
- E011106-HD/8 FDA UDI
- Primary DI / UDI-DI
- 04260759930133 EUDAMEDFDA UDI
- Basic UDI-DI
- 426075993E1006C EUDAMED
- Direct Marketing DI
- 04260759930133 EUDAMED
- 510(k) Number
- K211291 FDA UDI
- FDA Product Code
- PGW FDA UDI
- EMDN Code
- Z12011401 SURGICAL NAVIGATION SYSTEM EUDAMED
- GMDN Term
- Multi-purpose stereotactic surgery system FDA UDI
Classification
- Device Class
- Class IIa 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
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
MR Unsafe FDA UDI
Navigation Unit Cube4D by Fiagon GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 426075993E1006C | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Fiagon GmbH
- EUDAMED SRN
- DE-MF-000010763
Sources (2)
- EUDAMED e9557659-bca6-421c-9352-e239182e5dc3 61 fields · synced Jul 9, 2026
- FDA UDI 86d7b2c5-4512-43bc-89e3-876a11a8fee6 35 fields · synced May 30, 2026