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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Navigation Headrest Horseshoe — Class I MDR by Fiagon GmbH

MD Atlas
Fiagon GmbH

EUDAMED last updated this device on Nov 20, 2024

Navigation Headrest Horseshoe

426075993E0026B

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fiagon GmbH
UDI-DI code: 04260759930287
Reference / catalog number: E 01 1005

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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.

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

Device identification

Trade name: Navigation Headrest Horseshoe
UDI-DI code: 04260759930287
Basic UDI-DI: 426075993E0026B
Reference / catalog number: E 01 1005
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: Headrest for Navigation, Navigation sensor support, max loaad 10 kg, to be used with mounted Navigation sensor type: A 01 1000
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 150 MU29

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

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Certificates

Certificate health across this manufacturer's portfolio.

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