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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

IPK11000 — Class I MDR by INFOMEDICA za…

MD Atlas
INFOMEDICA za proizvodnju i promet medicinskim proizvodima, društvo s ograničenom odgovornošću

EUDAMED last updated this device on Jun 18, 2025

IPK11000

38575001356IPK1V5

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: INFOMEDICA za proizvodnju i promet medicinskim proizvodima, društvo s ograničenom odgovornošću
UDI-DI code: 03857500135612
Reference / catalog number: IPK11000

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Manufacturer information

Organization name: INFOMEDICA za proizvodnju i promet medicinskim proizvodima, društvo s ograničenom odgovornošću
SRN: HR-MF-000035358
Manufacturer status: Active

Market distribution

Primary placement in Croatia; available across 1 country total.

Placed on the market in Croatia; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 03857500135612
Basic UDI-DI: 38575001356IPK1V5
Reference / catalog number: IPK11000
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: iRIS PACS is a medical software package designed for - Transmitting patient and exam information in the form of DICOM MWL to imaging devices - Acquisition and storage of DICOM medical images - Display of medical images for purposes of review
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z110603PICTURE ARCHIVING AND COMMUNICATION SYSTEMS

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.