Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

PointerShell Universal — Class I MDR by Fiagon GmbH

MD Atlas
Fiagon GmbH

EUDAMED last updated this device on Nov 20, 2024

PointerShell Universal

426075993E0056H

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fiagon GmbH
UDI-DI code: 04260759930393
Reference / catalog number: E 01 2904

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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 Universal
UDI-DI code: 04260759930393
Basic UDI-DI: 426075993E0056H
Reference / catalog number: E 01 2904
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 2.5 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

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

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.