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Terviseamet

Medical device

MSA code 16804
Põhi UDI-DI
Seadme klass In vitro diagnostikameditsiiniseade
Meditsiiniseadmete nomenklatuur
Risk class IVD selftest 98/79/EÜ
Appliance -
Device name (in Estonian) FlowFlex SARS COV-2 antigeeni kiirtest (enesetest)
Device name (in English) FlowFlex SARS COV-2 antigent rapid test (self-testing)
Intended use (is Estonian) Kiirtest SARS COV-2 nukleokapsiidi antigeenide tuvastamiseks nina eesosa kaape proovides.
Intended use (in English) A rapid test for the detection of SARS-COV-2 nucleocapsid antigens in anterior nasal swab specimens.
Type/model/article number L031-118M5, L031-118N5, L031-118W5, L031-118P5, L031-118Z5, L031-118R5
Notified body 0123
Manufacturer Acon Biotech (Hangzhou) Co.,Ltd
Authorised representative MedNet GmbH
In register from 08/03/2021
Status Active
EHK soodustus EHK soodustus puudub
Documents related to medical device model
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