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Medical device

MSA code 16967
UDI code
Seadme klass Meditsiiniseade
Risk class IIb
Appliance -
Device name (in Estonian) Efficia väliskäpad
Device name (in English) Efficia External Paddles
Intended use (is Estonian) Efficia väliskäpad on mõeldud kasutamiseks Efficia DFM100 ja HeartStart Intrepidi seadmetega, kasutades käppasid patsiendi rindkerel EKG salvestamiseks ja/või defibrilleerimiseks.
Intended use (in English) The Efficia External Paddles are intended to be used with the Efficia DFM100 and HeartStart Intrepid devices by applying the paddles to the patient’s chest to obtain an ECG and/or deliver defibrillation therapy.
Type/model/article number 989803196431
Notified body 0123
Manufacturer Philips Goldway (Shenzhen) Industrial Inc.
Authorized spokesman Shanghai International Holding Corp.GmbH (Europe)
In register from 10/13/2021
Status Active
EHK soodustus EHK soodustus puudub
Documents related to medical device model
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