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Adhesive Pad
EUDAMEDFDA UDIClass I (EU MDR)
Ref E 00 3001Model Accessory to Cube4D Navigation System / fixation material
by Fiagon GmbH
Identity
- Trade Name
- Adhesive Pad EUDAMEDFDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- Adhesive pads for fixation of patient localizer for image guided surgery. The device is accessory to the Cube 4D Navigation system. FDA UDI
- Model / Reference
- Accessory to Cube4D Navigation System / fixation material EUDAMEDE 00 3001 EUDAMED1 FDA UDIE003001 FDA UDI
- Description
- Adhesive pads for fixation of patient localizer for image guided surgery. The device is accessory to the Cube 4D Navigation system. FDA UDI
Identifiers
- Catalog Number
- E 00 3001 FDA UDIE003001 FDA UDI
- Primary DI / UDI-DI
- 04260759930515 EUDAMEDFDA UDIEFIAE0030011 FDA UDI
- Basic UDI-DI
- 426075993E0076M EUDAMED
- FDA Product Code
- PGW FDA UDI
- EMDN Code
- Z12011485 SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Multi-purpose stereotactic surgery system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDIIn Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 0.036 Kilogram FDA UDI
Adhesive Pad by Fiagon GmbH — Class I — 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 | 426075993E0076M | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fiagon GmbH
- EUDAMED SRN
- DE-MF-000010763
Sources (3)
- EUDAMED 3dcf7f5b-d6a6-4f18-b875-98a2fe65e531 61 fields · synced Aug 4, 2026
- FDA UDI 35e43553-be83-4f3f-812c-aec5f0be13b9 37 fields · synced May 30, 2026
- FDA UDI ff16ba74-4826-454a-8b3c-f6a7d61ebea1 35 fields · synced May 30, 2026