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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

172035 — Class I MDR by AKTORmed GmbH

MD Atlas
AKTORmed GmbH

EUDAMED last updated this device on Nov 3, 2025

172035

4260463840018T

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AKTORmed GmbH
UDI-DI code: 04260463840353
Reference / catalog number: 172035

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Manufacturer information

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

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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.

Critical warnings

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

CW999
Never use the SOLOASSIST II-models if you detected any damage. Contact the corresponding service.
CW999
The SOLOASSIST II-models or the associated POWER SUPPLY may not be placed directly adjacent to other equipment or stacked with other equipment. If it is necessary to operate the device close to other equipment and stacked with other equipment, the SOLOASSIST II-models should be monitored in order to check the proper operation with this arrangement.

Market distribution

Primary placement in Austria; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 04260463840353
Basic UDI-DI: 4260463840018T
Reference / catalog number: 172035
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: The POWER SUPPLY supplies the SOLOASSIST II-models with the required operating voltage and is designed for a wide input voltage range.
Additional information URL: https://aktormed.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z1202018099REMOTE CONTROL ROBOT-ASSISTED ENDOSCOPIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES - OTHER

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

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Software identification