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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

EKG Series — Class IIa MDR by International Group…

MD Atlas
International Group medical technology and electronics GmbH

EUDAMED last updated this device on Feb 12, 2024

EKG Series

42557167IGEKGKK

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: International Group medical technology and electronics GmbH
UDI-DI code: 04255716700041
Reference / catalog number: EKGI, EKGII

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Manufacturer information

Organization name: International Group medical technology and electronics GmbH
SRN: DE-MF-000025679
Manufacturer status: Active

Critical warnings

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

CW018
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Feb 13, 2024	Feb 13, 2029

Device identification

Trade name: EKG Series
UDI-DI code: 04255716700041
Basic UDI-DI: 42557167IGEKGKK
Reference / catalog number: EKGI, EKGII
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)

Z12050301GENERAL PURPOSE ELECTROCARDIOGRAPHS

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

LAM II Series42557167IGLAMIIPCOn the market LAM III Series42557167IGLAMIIIXQOn the market TAB II Series42557167IGTABIIQDOn the market TAB III Series42557167IGTABIIIYKOn 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.