J.able Bio got the CE-IVD approved for the saliva collection kit

Saliva Collection Kit, manufactured by J.able Bio, after the effort to apply the CE for two months, we finally get the approval by Germany DIMDI

The saliva collection kit consists of a funnel, cap, tube and/or preservation solution. For the collection of human saliva samples.

EU-Representative : Luxus Lebenswelt GmbH

Kochstr.1, 47877, Willich, Germany

DIMDI: DE/0000047791

Lin Sun

Tel: 0049- 1715605732

E-mail: info.m@luxuslw.de

Classification : Others of ANNEX II of IVDD

Conformity Assessment Route: Annex III

General applicable directives:

In Vitro Diagnostic Medical Devices DIRECTIVE 98/79/EC

Harmonized standards:

EN ISO 15223-1:2016

EN ISO 14971:2012

Post time: Jun-09-2021