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Product Safety and Regulatory Compliance – Dolphi & LEX Latex Condoms

Material Information – Natural Rubber Latex

These condoms are made from natural rubber latex. Latex may cause allergic reactions in individuals with known or suspected latex sensitivity. If irritation, burning or discomfort occurs, discontinue use and consult a healthcare professional.

General Safety and Usage Information (GPSR)

This product is a medical device. Use it according to the instructions for use or the information provided on the packaging.

• Single Use: Product for single use only. Do not reuse. Dispose of used condoms in household waste. Do not flush in the toilet.
• Package Integrity: Do not use if the foil or packaging is damaged, opened or shows signs of deterioration.
• Instructions: Carefully read the instructions before use.
• Storage: Store in a cool, dry place, away from heat and direct sunlight.
• Protection Notice: No method of contraception provides 100% protection against pregnancy, HIV or other sexually transmitted infections (STIs).
• Additional Lubricants: Use only lubricants that are safe for latex condoms. Oil-based lubricants may damage latex.

Medical Device Certification

CE Marking – compliant with EU medical device regulations.

Notified Body: Identification number may vary depending on the production batch (e.g., 2460 – DNV Product Assurance AS or 0483). Please check the packaging for the specific CE number.

Responsible Economic Operators

Manufacturer:
MedPack Swiss AG
Lammichstrasse 6, 8866 Ziegelbrücke, Switzerland
Email: info@medpackswiss.com

EU Regulatory Reference:
Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety.