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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

161773 — Class I MDR by AKTORmed GmbH

MD Atlas
AKTORmed GmbH

EUDAMED last updated this device on Nov 3, 2025

161773

4260463840018T

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AKTORmed GmbH
UDI-DI code: 04260463847734
Reference / catalog number: 161773

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Manufacturer information

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

Related devices

1618224260463840038XOn the market 1720884260463840038XOn the market 2024264260463840018TOn the market 2024454260463840048ZOn the market 2124804260463840018TOn the market

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

1 warning recorded — scroll inside the panel to see all entries.

CW999
Never use the SOLOASSIST II i / ARTip solo if you detected any damage. Contact the corresponding service.

Market distribution

Primary placement in France; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 04260463847734
Basic UDI-DI: 4260463840018T
Reference / catalog number: 161773
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 TENSION SLEEVE accepts the endoscope in a secure and gentle way.
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification