ENDOTEQ 1940

Trade name

ENDOTEQ 1940

UDI-DI code

42624941200150

Basic UDI-DI

B-42624941200150

Reference / catalog number

ETQ1940

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

The ENDOTEQ laser is used to apply laser radiation to soft tissue for medical purposes

Additional information URL

http://www.endoteq.de/

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12011016DIODE SURGICAL LASER

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

• CW013

  Laser treatment controlled area
• CW010

  EUDAMED did not publish a description for this code.
• CW147

  EUDAMED did not publish a description for this code.
• CW167

  Protective eyewear
• CW018

  EUDAMED did not publish a description for this code.
• CW036

  Use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by the manufacturer of the laser as replacement parts for internal components, may result in increased emissions or decreased immunity of the laser.
• CW999

  The treatment is contraindicated in all cases where the use of laser as a surgical modality is contraindicated (where heat could present a clinical risk), including where a clinical procedure is limited by anesthesia requirements or site access. In addition, applications at the central nervous system and the central circulatory system are not allowed.
• CW999

  The ENDOTEQ Laser may only be operated by personnel that underwent relevant training for the device and that possess the necessary knowledge for the laser's applications.

No certificate specifically references this device's Basic UDI-DI.