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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

2 — Class IIb MDR by MEDORO s.r.o.

MD Atlas
MEDORO s.r.o.

EUDAMED last updated this device on Jul 22, 2025

2

859421232DICOMPASSGM

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MEDORO s.r.o.
UDI-DI code: 08594212320022
Reference / catalog number: 2

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Manufacturer information

Organization name: MEDORO s.r.o.
SRN: CZ-MF-000024306
Manufacturer status: Active

Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement	Aug 26, 2018	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08594212320022
Basic UDI-DI: 859421232DICOMPASSGM
Reference / catalog number: 2
Issuing entity: GS1

Classification

Risk category: Class IIb
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)

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

1859421232DICOMPASSGMOn the market

Certificates

Certificate health across this manufacturer's portfolio.

2022-MDR/QS-020Amended
Quality management systemNotified body: 2265Expiry: Sep 9, 2027
2022-MDR/QS-020Issued
Quality management systemNotified body: 2265Expiry: Sep 9, 2027