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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

PointerShell 5mm — Class I MDR by Fiagon GmbH

MD Atlas
Fiagon GmbH

EUDAMED last updated this device on Nov 20, 2024

PointerShell 5mm

426075993E0056H

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fiagon GmbH
UDI-DI code: 04260759930379
Reference / catalog number: E 01 2901

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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: PointerShell 5mm
UDI-DI code: 04260759930379
Basic UDI-DI: 426075993E0056H
Reference / catalog number: E 01 2901
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 adapter for navigation, reusable, for instrument shafts of 4.7 mm to 5 mm
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

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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.