BETTER AGTop Qualität zu Herstellerpreisen

BETTER AG General-Guisan-Str. 86300 Zug, Schweiz

Kontakt: D / AT: + 49 (0)30 62 93 34 20CH: + 41 (0) 71 58 80 248E-Mail: info@OdemShop.com

Bei derBAG gelistet Schnelltest zurEigenanwendung

Eidgenössisches Departement des Innern EDI

Bundesamt für Gesundheit BAG

Taskforce BAG Covid-19 AG Testung

03.06.2021

Webseite Covid-19 Testung

Site internet Tests COVID-19

Sito web Test COVID-19

Abgabe durch die Apotheken

Distribution par les pharmacies

Distribuzione per farmacia

Hersteller

Fabricant

Azienda

SD Biosensor, Inc., Republic of Korea

Becton, Dickinson and Company (BD), USA

ACON Biotech (Hangzhou) Co. Ltd., China

Healgen Scientific Limited Liability Company, USA

BD Kit for Rapid Detection of SARS-CoV-2

Die Schnelltests zur Eigenanwendung sind ausschliesslich für den nasalen Abstrich validiert und nur dementsprechend

anzuwenden. Informationen bezüglich des Einsatzes der Schnelltests finden Sie auf der BAG-Webseite Covid-19-Testung.

Les tests rapides pour auto-application sont validés pour les prélèvements nasaux uniquement et ne doivent donc être utilisés qu'en

conséquence. Ces informations sur l'emploi prévu des tests rapides sont disponibles sur le site web de l'OFSP Tests COVID-19.

I test rapidi per uso proprio sono convalidati solo per i tamponi nasali e dovrebbero essere usati solo di conseguenza.. Le

informazioni su come utilizzare i test rapidi sono disponibili sul sito internet dell'UFSP «Test COVID-19».

Sars-CoV-2-Antigen-Schnelltests zur Eigenanwendung (Sars-CoV-2 Selbsttest)1

Tests rapides pour l'antigène du SARS-CoV-2 pour auto-application (autotest SARS-CoV-2)

Test rapidi dell'antigene SARS-CoV-2 per uso proprio (test autodiagnostici SARS-CoV-2)

SARS-CoV-2 Rapid Antigen Test Nasal

CLINITEST® Rapid COVID-19 Antigen Self-Test

Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)

Antigen Schnelltest

Tests rapides antigéniques

Test antigenici rapidi

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EC CertificateEC Design-Examination CertificateDirective 98/79/EC on In Vitro Diagnostic Medical Devices (IVDD), Annex III (6)(Devices for self-testing)No. V9 042074 0032 Rev. 00

Page 1 of 3TÜV SÜD Product Service GmbH is Notified Body with identification no. 0123

TÜV SÜD Product Service GmbH • Certification Body • Ridlerstraße 65 • 80339 Munich • Germany

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.No.210 Zhenzhong RoadWest Lake District310030 HangzhouPEOPLE'S REPUBLIC OF CHINA

Product: In Vitro diagnostic devices for self testing

The Certification Body of TÜV SÜD Product Service GmbH declares that a design examination has been carried out on the respective devices in accordance with IVDD Annex III (6). The design of the devices conforms to the requirements of this Directive. All applicable requirements of the testing and certification regulation of TÜV SÜD Group have to be complied with. For details and certificate validity see: www.tuvsud.com/ps-cert?q=cert:V9 042074 0032 Rev. 00

Report No.: SH2110605

Valid from: 2021-05-14Valid until: 2024-05-26

Date, 2021-05-14

Christoph DicksHead of Certification/Notified Body

EC CertificateEC Design-Examination CertificateDirective 98/79/EC on In Vitro Diagnostic Medical Devices (IVDD), Annex III (6)(Devices for self-testing)No. V9 042074 0032 Rev. 00

Page 2 of 3TÜV SÜD Product Service GmbH is Notified Body with identification no. 0123

TÜV SÜD Product Service GmbH • Certification Body • Ridlerstraße 65 • 80339 Munich • Germany

Model(s): SARS-CoV-2 Antigen Rapid Test (Self-Testing)

Facility(ies): Acon Biotech (Hangzhou) Co., Ltd.No.210 Zhenzhong Road, West Lake District, 310030 Hangzhou, PEOPLE'S REPUBLIC OF CHINA

Model name: Model number:

Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-11855Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118L5Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118T5Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118A5Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118U5Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118V5Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118Q5Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118M5Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118N5Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118W5Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118P5Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118Y5Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118Z5Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118R5

Hughes SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-11853EHughes SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118A3EHughes SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118Q3EHughes SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118M3EHughes SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118P3EHughes SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118R3E

Quik Check SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-11857Quik Check SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118A7Quik Check SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118Q7Quik Check SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118M7Quik Check SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118P7Quik Check SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118R7

EC CertificateEC Design-Examination CertificateDirective 98/79/EC on In Vitro Diagnostic Medical Devices (IVDD), Annex III (6)(Devices for self-testing)No. V9 042074 0032 Rev. 00

Page 3 of 3TÜV SÜD Product Service GmbH is Notified Body with identification no. 0123

TÜV SÜD Product Service GmbH • Certification Body • Ridlerstraße 65 • 80339 Munich • Germany

DIAQUICK SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-11853JDIAQUICK SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118A3JDIAQUICK SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118Q3JDIAQUICK SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118M3JDIAQUICK SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118P3JDIAQUICK SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118R3J

Swiss Point of care SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-11853DSwiss Point of care SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118A3DSwiss Point of care SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118Q3DSwiss Point of care SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118M3DSwiss Point of care SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118P3DSwiss Point of care SARS-CoV-2 Antigen Rapid Test (Self-Testing) REF L031-118R3D