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Organization name
UDI-DI code
Reference / catalog number

RIWOtrack Clipsensor stenosis — Class I MDR by Fiagon GmbH

MD Atlas
Fiagon GmbH

EUDAMED last updated this device on Jan 22, 2025

RIWOtrack Clipsensor stenosis

426075993S0089R

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fiagon GmbH
UDI-DI code: 04260759930065
Reference / catalog number: N 01 2954

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Manufacturer information

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

Related devices

4K Navigation Unit Cube4D426075993E1006COn the market Adapter for Clipsensor426075993S0069MOn the market Adapter for Clipsensor stenosis426075993S0069MOn the market Adapter for Flexsensor426075993S0059KOn the market Adhesive Pad426075993E0076MOn the market

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: RIWOtrack Clipsensor stenosis
UDI-DI code: 04260759930065
Basic UDI-DI: 426075993S0089R
Reference / catalog number: N 01 2954
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Instrument tracker for RIWOspine VERTEBRIS instruments. Accessory to RIWOtrack Navigation System.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12011480SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES

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

Certificates

Certificate health across this manufacturer's portfolio.

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