Certificate No. 60148169

Certificate Number: 60148169
Certificate Holder: livetec Ingenieurbüro GmbH

Marie-Curie-Str. 8
79539 Lörrach
Germany
Scope:

Devices for stimulation or inhibition, monitoring devices
of vital physiological parameters, devices for
utilising non-ionizing radiation, and active surgical device
(see attachment for products included)
Replaces Certificate, Registration No.: HD 60106096 0001
Products included:
Devices utilising non-ionizing radiation:
- Lasotronic MTL 100 LDU8021 PN-100, MTL LDU8021PN
- Laserdusche PowerTwin 21 LDU8021 PN, LDU 8021 PN-100
Active surgical devices:
- HAT 500 Generator, 100 Watts, 75 Watts, 50 Watts, 30 Watts
- HAT 500 Pump
- liveGEN 100, liveGEN 75, liveGEN 50, liveGEN 30
- liveCOOL
-LEONARDO FLOW Irrigation Pump
Devices for stimulation or inhibition:
- external cardiac pacemaker Pace T10, Pace T20

Fulfilled Standards: Richtlinie 93/42/EWG
Certificate Type: Vollst. QMS, Anhang II MDD

EC declaration of conformity (Full quality assurance system)
Certificate according to Annex II Section 3 of the EC Directive 93/42/EEC concerning Medical Devices

The Notified Body hereby certifies the application of the quality system by the manufacturer approved for the design, manufacture and final inspection of the products concerned, as specified in Annex II, Section 3 of the EC directive 93/42/EEC.

The manufacturer is subject to audit as laid down in Sections 3.3 and 4 and to Community surveillance as specified in Section 5.

This approval can be used by the company in line with the declaration of conformity.