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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

REF1 — Class IIa MDR by x-cardiac GmbH

MD Atlas
x-cardiac GmbH

EUDAMED last updated this device on May 24, 2023

REF1

426075298xcp01YC

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: x-cardiac GmbH
UDI-DI code: 04260752980012
Reference / catalog number: REF1

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Manufacturer information

Organization name: x-cardiac GmbH
SRN: DE-MF-000007826
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW011
x-cardiac-platform is not a diagnostic tool or service and its results require careful interpretation by a physician. For the x-c-renal-injury plug-in, patients with a preoperative creatinine level above 4 mg/dL are contraindicated.

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Nov 14, 2024	Still on market
Austria	Nov 14, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260752980012
Basic UDI-DI: 426075298xcp01YC
Reference / catalog number: REF1
Issuing entity: GS1

Classification

Risk category: Class IIa
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)

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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

This device is not currently linked to any other device.

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.