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

001 — Class IIb MDR by mediaire GmbH

MD Atlas
mediaire GmbH

EUDAMED last updated this device on Aug 22, 2023

001

426073764mbV4MB

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: mediaire GmbH
UDI-DI code: 04260737640016
Reference / catalog number: 001

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: mediaire GmbH
SRN: DE-MF-000010713
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 3 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
Austria		Still on market
Italy		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260737640016
Basic UDI-DI: 426073764mbV4MB
Reference / catalog number: 001
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: The product is intended for automatic labeling, visualization and volumetric quantification of 3D MRI data (in DICOM format) of the head. The software automates the currently manual process of identifying, labeling and volumetric calculation of segmented brain structures on 3D MRI images. The calculated volumetric data, in addition to the image data at hand, can assist radiologists in detecting neurological diseases. The volumetric data obtained alone is not sufficient to establish a diagnosis and is not intended to do so.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11059092VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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

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.

Related devices

004426073764mbV4MBOn the market 000426073764mbV4MBOn the market 008426073764KNE017GOn the market 009426073764KNE017GOn the market 007426073764KNE017GOn the market