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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

2.X — Class IIb MDR by MX Healthcare GmbH

MD Atlas
MX Healthcare GmbH

EUDAMED last updated this device on Apr 12, 2023

2.X

426073218VARAA3

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MX Healthcare GmbH
UDI-DI code: 04260732180005
Reference / catalog number: 2.X

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Manufacturer information

Organization name: MX Healthcare GmbH
SRN: DE-MF-000006986
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW011
Not to be used for full automation of the diagnosis.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Feb 24, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260732180005
Basic UDI-DI: 426073218VARAA3
Reference / catalog number: 2.X
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11030292MAMMOGRAPHY SYSTEMS - 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

Related devices

Vara AI426073218VaraAIUJOn the market Vara MG426073218VARAA3On 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.