Chigoba cha nkhope yopangira opaleshoni (F-Y1-A Type IIR)
Kapangidwe kazinthu
Zosefera dongosolo lakonzedwa ndi layered ndi pamwamba 25g sanali nsalu, wachiwiri wosanjikiza 25g BFE99 kusefera zakuthupi, mkati wosanjikiza 25g sanali nsalu.
Kuchuluka kwa ntchito
Amagwiritsidwa ntchito kuphimba pakamwa, mphuno ndi nsagwada za wogwiritsa ntchito, ndipo amapereka chotchinga chakuthupi kuti ateteze kufalikira kwa tizilombo toyambitsa matenda, madzi a m'thupi, particles, etc.
F-Y1-A ndi chigoba cha nkhope ya opaleshoni.
UMDN kodi: 12-458
Gulu: Gulu 1
Lamulo: Malinga ndi Lamulo 1, Annex V111, Mutu III wa (EU) MDR 2017/745
Njira yowunikira mogwirizana: ANNEX II + ANNEX III + Article 19 ya (EU) MDR 2017/745
Zalengezedwa ndi wopanga kuti F-Y1-A ikumana ndi zomwe Medical Device Regulation (EU) MDR 2017/745 ya Nyumba Yamalamulo yaku Europe ndi Council ya 5 Epulo 2017 pazida zamankhwala.EU Declaration Conformity imagwiritsidwa ntchito pansi pa udindo wa wopanga.
F-Y1-A muyeso wagwiritsidwa ntchito:
EN ISO 13485:2016, EN ISO 14971:2012, EN 14683:2019 +AC:2019, BS EN ISO 15223-1:2016, EN ISO 10933-1:2009/AC:2010: 9 EN ISO 15223-1:2016, EN ISO 10933-1:2009/AC:2010: 9 9 ISO 10993-10:2010, EN 1041:2008
