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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

212510 — Class I MDR by AKTORmed GmbH

MD Atlas
AKTORmed GmbH

EUDAMED last updated this device on Nov 3, 2025

212510

42604638400797

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AKTORmed GmbH
UDI-DI code: 04260463845105
Reference / catalog number: 212510

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Manufacturer information

Organization name: AKTORmed GmbH
SRN: DE-MF-000006136
Manufacturer status: Active

Critical warnings

4 warnings recorded — scroll inside the panel to see all entries.

CW999
Only use original accessories. The use of accessories not approved by the manufacturer may endanger the patient or damage the unit.
CW010
Observe all safety instructions in this instructions for use as well as the instructions for use for the SOLOASSIST.
CW999
A critical situation may occur if an unintended movement is performed. Unintentional means that no command was given by JOYSTICK / REMOTE CONTROL / VOICE CONTROL and the appliance moves anyway. In this case IMMEDIATELY press the red EMERGENCY STOP button.
CW018
The restrictions on the use of the SOLOASSIST apply.

Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260463845105
Basic UDI-DI: 42604638400797
Reference / catalog number: 212510
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: —
Additional information URL: https://aktormed.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z1202018002COMMAND CONSOLES FOR ENDOSCOPIC SURGERY

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

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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.