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FlexTube 3mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref E 01 2104Model Cube 4D Navigation System
by Fiagon GmbH
Identity
- Trade Name
- FlexTube 3mm EUDAMEDFDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- The device FlexTube 3mm is a navigation probe with suction function for image guided surgery. The device is component to the Cube4D Navigation system. FDA UDI
- Model / Reference
- Cube 4D Navigation System EUDAMEDE 01 2104 EUDAMEDE012104 FDA UDI
- Description
- The device FlexTube 3mm is a navigation probe with suction function for image guided surgery. The device is component to the Cube4D Navigation system. FDA UDI
Identifiers
- Catalog Number
- E012104 FDA UDI
- Primary DI / UDI-DI
- 04260759930324 EUDAMEDFDA UDI
- Basic UDI-DI
- 426075993E1006C EUDAMED
- Direct Marketing DI
- 04260759930324 EUDAMED
- 510(k) Number
- K141456 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
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
FlexTube 3mm 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 e66bc9a2-33d4-448e-a16c-c10c2a0a211b 61 fields · synced Jun 18, 2026
- FDA UDI d39759c6-270b-4b75-8815-ee11ccdb2c54 36 fields · synced May 30, 2026