J.able Bio ya sami amincewar CE-IVD don kayan tattara saliva

Kit ɗin Tarin Saliva, wanda J.able Bio ya ƙera, bayan ƙoƙarin yin amfani da CE na tsawon watanni biyu, a ƙarshe mun sami amincewa daga Jamus DIMDI.

Kit ɗin tattara saliva ya ƙunshi mazurari, hula, bututu da/ko maganin adanawa.Domin tarin samfurorin ruwan mutum.

Wakilin EU: Luxus Lebenswelt GmbH

Kochstr.1, 47877, Willich, Jamus

DIMDI: DE/0000047791

Lin Sun

Lambar waya: 0049-1715605732

Imel:info.m@luxuslw.de

Rabewa:Wasu na ANNEX II na IVDD

Hanyar Ƙimar Daidaitawa:Annex III

Gabaɗayan umarni masu dacewa:

A cikin Vitro Diagnostic Medical Devices DIRECTIVE 98/79/EC

Ma'auni masu jituwa:

TS EN ISO 15223-1: 2016

TS EN ISO 14971: 2012


Lokacin aikawa: Juni-09-2021