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Organization name
UDI-DI code
Reference / catalog number

RIWOtrack Navigation Unit Cube4D — Class IIa MDR by Fiagon GmbH

MD Atlas
Fiagon GmbH

EUDAMED last updated this device on Jan 22, 2025

RIWOtrack Navigation Unit Cube4D

426075993S1009E

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fiagon GmbH
UDI-DI code: 04260759930058
Reference / catalog number: E 01 1106 -4K/8 -RW

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Manufacturer information

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

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jan 1, 2025	Still on market

Device identification

Trade name: RIWOtrack Navigation Unit Cube4D
UDI-DI code: 04260759930058
Basic UDI-DI: 426075993S1009E
Reference / catalog number: E 01 1106 -4K/8 -RW
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, 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
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Software identification