RIWOtrack Navigation Unit Cube4D
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
by Fiagon GmbH
Identity
- Trade Name
- RIWOtrack Navigation Unit Cube4D EUDAMEDRIWOtrack Cube4D FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- Navigation unit, Component of RIWOtrack Navigation System FDA UDI
- Model / Reference
- RIWOtrack Navigation System EUDAMEDE 01 1106 -4K/8 -RW EUDAMEDE011106-4K/8 RW FDA UDI
- Description
- Navigation unit, Component of RIWOtrack Navigation System FDA UDI
Identifiers
- Catalog Number
- E011106-4K/8 RW FDA UDI
- Primary DI / UDI-DI
- 04260759930058 EUDAMEDFDA UDI
- Basic UDI-DI
- 426075993S1009E EUDAMED
- Direct Marketing DI
- 04260759930058 EUDAMED
- 510(k) Number
- K230700 FDA UDI
- FDA Product Code
- OLO 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
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
The RIWOtrack Navigation Unit Cube4D is a Class IIa medical device classified under nomenclature code Z12011401, designed as a component of the RIWOtrack Navigation System. It functions as an active navigation unit, providing real-time spatial tracking and guidance for surgical or procedural applications, ensuring precise instrument positioning within clinical settings.
This non-sterile, non-reusable device is supplied as part of the RIWOtrack Navigation System with reference code E 01 1106 -4K/8 -RW. It is intended for use in environments requiring accurate navigation, such as operating rooms or interventional suites, and complies with FDA 510(k) and MDR regulatory standards. The device is not implantable, does not contain human or animal tissues, and is marked with a unique UDI (426075993S1009E) for traceability.
Frequently asked questions
What is the RIWOtrack Navigation Unit Cube4D used for in clinical settings?
The RIWOtrack Navigation Unit Cube4D is designed as an active navigation component within the RIWOtrack Navigation System, providing real-time spatial tracking and precise instrument guidance. It is specifically intended for use in environments like operating rooms or interventional suites where accurate navigation is critical, such as during surgical or procedural applications.
Is the RIWOtrack Navigation Unit Cube4D sterile and reusable, or is it meant for single-use?
The RIWOtrack Navigation Unit Cube4D is explicitly marked as non-sterile and non-reusable. It is supplied as part of the RIWOtrack Navigation System (reference code E 01 1106 -4K/8 -RW) and is intended for single-use only, as indicated by the specifications.
How is the RIWOtrack Navigation Unit Cube4D supplied, and what reference code should be used?
The device is supplied as part of the RIWOtrack Navigation System with the reference code E 01 1106 -4K/8 -RW. It is not sold or distributed separately but is included as a component of the full system, ensuring compatibility and proper functionality.
Does the RIWOtrack Navigation Unit Cube4D contain any human or animal tissues, or is it implantable?
No, the RIWOtrack Navigation Unit Cube4D does not contain human or animal tissues, nor is it designed for implantation. The device is classified as non-implantable (marked as 0 in the specifications) and is intended for external use in navigation systems.
What regulatory pathways does the RIWOtrack Navigation Unit Cube4D follow, and how can I verify its traceability?
The device complies with FDA 510(k) and MDR (Medical Device Regulation) standards, confirming its regulatory approval. For traceability, it is marked with a unique UDI (426075993S1009E), which includes a UDI-DI (04260759930058) and a UDI-PI (embedded in the device). This allows for full product identification and tracking throughout its lifecycle.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163209 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K133573 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K151156 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K230700 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K162176 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 426075993S1009E | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fiagon GmbH
- EUDAMED SRN
- DE-MF-000010763
Sources (3)
- EUDAMED 9ab013a5-5492-4910-9f9a-b9905cd26264 61 fields · synced Sep 18, 2026
- FDA UDI 76411c65-e6f9-49d1-b491-691e9a887c30 35 fields · synced May 30, 2026
- FDA 510(k) K163209 1 fields · synced May 18, 2026