171943

Organization name

AKTORmed GmbH

SRN

DE-MF-000006136

Manufacturer status

Active

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

• CW999

  The ENDOFIX EXO must not be used outside of the fields of application detailed above. The ENDOFIX EXO may be used exclusively for holding and moving an endoscope.
• CW999

  The ENDOFIX EXO is not suitable for outpatient interventions where the patient is only under partial anesthesia.
• CW999

  In case of intraoperative complications not due to the use of the ENDOFIX EXO, it may still be in order to remove the device as fast as possible from the OR surroundings in order to have better access to the patient.
• CW999

  MEDICAL ELECTRICAL DEVICES are subject to special precautionary measures in regard to EMC. The ENDOFIX EXO may be installed and operated only in accordance with the EMC information contained in this manual.
• CW999

  Never use the ENDOFIX EXO if you detected any damage. Contact the corresponding service.
• CW999

  The ENDOFIX EXO 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 ENDOFIX EXO should be monitored in order to check the proper operation with this arrangement.
• CW009

  STERILE COVER: Do not reuse
• CW999

  Never use the ENDOFIX EXO in the OR without having been instructed by an authorised person in its safe use.
• CW999

  This symbol indicates safety information. Non-compliance with the corresponding information may lead to damage or even injuries for the patients and / or the user.

Primary placement in France; available across 1 country total.

Trade name

not provided

UDI-DI code

04260463849431

Basic UDI-DI

4260463840028V

Reference / catalog number

171943

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

incl. POWER SUPPLY, POWER CORD C7 and SUPPLY CABLE

Additional information URL

https://aktormed.com/

Clinical sizes

No clinical sizes registered for this device.

• Z12029099VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER
• Z129010MULTI-DISCIPLINARY HOLTER SYSTEMS

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification