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FlexArm Adapter for siderail
EUDAMEDClass I (EU MDR)
Ref E 01 1905Model Accessory to Cube 4D Navigation System / Navigation sensor support, Adapter
by Fiagon GmbH
Identity
- Trade Name
- FlexArm Adapter for siderail EUDAMED
- Model / Reference
- Accessory to Cube 4D Navigation System / Navigation sensor support, Adapter EUDAMEDE 01 1905 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260759930539 EUDAMED
- Basic UDI-DI
- 426075993E0106A EUDAMED
- Direct Marketing DI
- 04260759930539 EUDAMED
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Neurological stereotactic surgery system
FlexArm Adapter for siderail by Fiagon GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426075993E0106A | Class I | Active |
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Manufacturer
- Manufacturer
- Fiagon GmbH
- EUDAMED SRN
- DE-MF-000010763
Sources (1)
- EUDAMED a4f5e88d-9545-439f-aba6-7af2ee0f2070 61 fields · synced Jul 20, 2026