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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

aycan mobile — Class IIa MDR by aycan Digitalsysteme GmbH

MD Atlas
aycan Digitalsysteme GmbH

EUDAMED last updated this device on Jul 14, 2023

aycan mobile

42604765aycanPACSHA

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: aycan Digitalsysteme GmbH
UDI-DI code: 04260476510038
Reference / catalog number: aycan mobile

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Manufacturer information

Organization name: aycan Digitalsysteme GmbH
SRN: DE-MF-000006951
Manufacturer status: Active

Related devices

aycan store / aycan web42604765aycanPACSHAOn the market aycan workstation42604765aycanPACSHAOn the market

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: 04260476510038
Basic UDI-DI: 42604765aycanPACSHA
Reference / catalog number: aycan mobile
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: The medical device family 'aycan PACS' is a family of software products to be used as Picture Archiving and Communication Systems (PACS) for management, storage/archiving (optional), distribution, viewing, evaluation/post-processing (optional), reading and treatment planning (optional) of medical images and related information. The medical device must only be used by medical professionals with the necessary experience in the usage of PACS software and after reading the user manual.
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

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.