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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

1.0 — Class I MDR by MedCom Gesellschaft für…

MD Atlas
MedCom Gesellschaft für medizinische Bildverarbeitung mbH

EUDAMED last updated this device on Dec 9, 2022

1.0

0426030811MedStaAW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MedCom Gesellschaft für medizinische Bildverarbeitung mbH
UDI-DI code: 04260308110115
Reference / catalog number: 1.0

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Manufacturer information

Organization name: MedCom Gesellschaft für medizinische Bildverarbeitung mbH
SRN: DE-MF-000020585
Manufacturer status: Active

Critical warnings

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

CW011
Only qualified staff is allowed to use the system.
CW010
The user must always be aware that the quality of the output depends critically on the quality of input data, and any irregularities or uncertainties about input data units, identification, or quality of any other nature must be thoroughly investigated before the data is used.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260308110115
Basic UDI-DI: 0426030811MedStaAW
Reference / catalog number: 1.0
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11069080VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - HARDWARE

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

traXSta®0426030811traXStaHQOn 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.