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Organization name
UDI-DI code
Reference / catalog number

4K Navigation Unit Cube4D — Class IIa MDR by Fiagon GmbH

MD Atlas
Fiagon GmbH

EUDAMED last updated this device on Jan 22, 2025

4K Navigation Unit Cube4D

426075993E1006C

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fiagon GmbH
UDI-DI code: 04260759930157
Reference / catalog number: E 01 1106-4K/8

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Manufacturer information

Organization name: Fiagon GmbH
SRN: DE-MF-000010763
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: 4K Navigation Unit Cube4D
UDI-DI code: 04260759930157
Basic UDI-DI: 426075993E1006C
Reference / catalog number: E 01 1106-4K/8
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Image guided surgery system, 4K control unit with software
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12011401SURGICAL NAVIGATION SYSTEM

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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Certificates

Certificate health across this manufacturer's portfolio.

FI24/00000064Issued
Quality management systemNotified body: 0598Expiry: Oct 27, 2029