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Localizer Adhesive Pad C-Type
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref E 01 2202 CModel Cube 4D Navigation SystemRef E 01 2202Model Patient reference device for navigation
by Fiagon GmbH
Identity
- Trade Name
- Localizer Adhesive Pad C-Type EUDAMEDFDA UDILocalizer Adhesive Pad EUDAMED
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- The device localizer Adhesive Pad C-Type is patient reference device for image guided surgery. The device is component of the Cube4D Navigation System. FDA UDI
- Model / Reference
- Cube 4D Navigation System EUDAMEDE 01 2202 C EUDAMEDPatient reference device for navigation EUDAMEDE 01 2202 EUDAMEDE012202C FDA UDI
- Description
- The device localizer Adhesive Pad C-Type is patient reference device for image guided surgery. The device is component of the Cube4D Navigation System. FDA UDI
Identifiers
- Catalog Number
- E012202C FDA UDI
- Primary DI / UDI-DI
- 04260759930447 EUDAMEDFDA UDI04260759930430 EUDAMED
- Basic UDI-DI
- 426075993E1006C EUDAMED426075993E0066K EUDAMED
- Direct Marketing DI
- 04260759930447 EUDAMED04260759930430 EUDAMED
- FDA Product Code
- PGW FDA UDI
- EMDN Code
- Z12011401 SURGICAL NAVIGATION SYSTEM EUDAMEDZ12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Multi-purpose stereotactic surgery system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass 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
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
Localizer Adhesive Pad C-Type 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 (3)
- EUDAMED ff693f7a-ad43-4561-bafe-b3b572ddc61d 61 fields · synced Sep 18, 2026
- EUDAMED d7708688-e782-40ca-9541-97aee695179a 61 fields · synced May 19, 2026
- FDA UDI 80aefede-4b29-424d-aaf6-0025136fd35e 35 fields · synced May 30, 2026