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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

R0970 — Class I MDR by medigration GmbH

MD Atlas
medigration GmbH

EUDAMED last updated this device on Oct 30, 2024

R0970

4260224150053Y

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: medigration GmbH
UDI-DI code: 04260224155139
Reference / catalog number: R0970

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Manufacturer information

Organization name: medigration GmbH
SRN: DE-MF-000006255
Manufacturer status: Active

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: 04260224155139
Basic UDI-DI: 4260224150053Y
Reference / catalog number: R0970
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: Das Softwareprogramm „Domako“ dient dazu, anhand von DICOM Headerdaten (aus Bildern, Reports), die die bildgebenden Modalitäten liefern, Informationen über die Höhe der applizierten Energiedosis bzw. Aktivität sowie weitere Dosisparameter zu speichern und statistisch auszuwerten.
Additional information URL: https://www.bendergruppe.com/medigration/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11039092VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL 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

Related devices

DR400B-04260224156327On the market Version 4.2B-04260224151421On the market Version 1.7B-04260224153173On 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.