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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

003 — Class IIb MDR by mediaire GmbH

MD Atlas
mediaire GmbH

EUDAMED last updated this device on Aug 22, 2023

003

426073764PRS01C9

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: mediaire GmbH
UDI-DI code: 04260737640030
Reference / catalog number: 003

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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: 04260737640030
Basic UDI-DI: 426073764PRS01C9
Reference / catalog number: 003
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 semi-automatic labeling, visualization and volumetric quantification of 3D MRI data (in DICOM format) of the prostate. The software automates the currently manual process of identifying, labeling and volumetric calculation of segmented prostate structures on 3D MRI images. The calculated volumetric data, in addition to the image data at hand, can assist trained medical professionals in the interpretation of prostate MR studies. Diagnosis should not be made solely based on the analysis performed using mdprostate.
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

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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.