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