The Federal Office for Safety in Health Care (BASG) warns of a counterfeit medical device that could be mistaken for the legitimate product "Juvéderm Ultra 4" from the manufacturer "Allergan Aesthetics, an AbbVie company".

The Federal Office for Safety in Health Care (BASG) warns against the use of rapid tests for the detection of sexually transmitted diseases (STDs) that were distributed via the website „thuistest.shop“ and “stdheimtest.de“. Based on the information available to the BASG, the legal compliance of the affected products cannot be sufficiently demonstrated and therefore the safety and performance of the products cannot be ensured. For this reason, the listed products are not allowed to be placed on the Union Market.

The Federal Office for Safety in Health Care (BASG) warns lay users against the use of rapid tests for the detection of sexually transmitted diseases (STDs) that were distributed via the website „thuistest.shop“ and “stdheimtest.de“. In contrast to the website’s operator claim, all listed products are not intended for self-testing by lay users, but for medical professionals.

The European Commission offers free webinars to prepare economic operators and Notified Bodies for mandatory use.

These tests for self-testing for the detection of sexually transmitted diseases (STDs) from the manufacturer Genesign Biotech (XIAMEN) Co, Ltd are also marketed under the brand name JAL Medical (Singapore) Pte. Ltd. These products do not bear a CE mark, which means that they do not fulfil the requirements for in-vitro diagnostics. The BASG has information that the manufacturer has not carried out the required EU conformity assessment procedure. These products are therefore not marketable on the EU market.

The Federal Office for Safety in Health Care (BASG) warns of a counterfeit medical device that could be mistaken for the legitimate product "Needleless Airtight Infusion Connector Protector" from the manufacturer "Zhejiang Runqiang Medical Instruments Co., Ltd.".

The Federal Office for Safety in Health Care (BASG) warns of a counterfeit medical device that could be mistaken for the legitimate product "Sculptra" from the manufacturer "Q-Med AB".

The Federal Office for Safety in Health Care (BASG) warns of non-conforming subcutaneous and absorbable PDO threads, marketed as “ARIEL PDO Threads”, along with associated cannulas intended for mechanical tightening of loose and sagging skin (facelifting).

The BASG has announced that the first four modules of the European Database on Medical Devices (EUDAMED) will be mandatory to use as from 28 May 2026.

The Federal Office for Safety in Health Care (BASG) warns against counterfeit medical devices. The product "Nasal Cannula, Luer-Lock F, PVC, adult (REF 1.4.3.3.5)" has been counterfeited. It cannot be ruled out that this product is also on the Austrian market. Counterfeit medical devices have no or an unpredictable effect and are to be classified as dangerous. They must not be used under any circumstances.