AGES eValidator Installation Instructions for installing the eValidator 24.2 The following basic requirements must be met: administrator privileges Microsoft Windows Installer 3.1 Microsoft .NET Frame

Document Change Control EU Region eCTD Validation Criteria Version 8.2 June 2025 The order of changes appears reverse to the timely manner. The most recent change is listed on the top. Version Number

Referenced at:

• AGES eValidator

Further information and amendments to the product information in all EU languages are available on the EMA website.

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  Link to the EMA Website

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 donor/the donor gametes have been permanently blocked.

Der Spender/die Spendergameten wurden gesperrt.

Referenced at:

• European Sperm Bank ApS - Donor: 26120 BJERGI

Recall due to deactivated serial numbers

The Federal Office for Safety in Health Care (BASG) has been informed by the ECDC (European Centre for Disease Prevention and Control) that confirmed autochthonous dengue cases have been recorded in oversea departments of France.

Dem Bundesamt für Sicherheit im Gesundheitswesen (BASG) wurde von der ECDC (European Centre for Disease Prevention and Control) mitgeteilt, dass bestätigte autochthone Dengue-Fälle in Übersee-Départements Frankreichs verzeichnet wurden.

Referenced at:

• Dengue-France

The Federal Office for Safety in Health Care (BASG) has been informed by the ECDC (European Centre for Disease Prevention and Control) that confirmed autochthonous cases of chikungunya have been recorded in oversea departments of France.