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Product Safety and Regulatory Compliance – UNIQ Condoms

General Safety and Usage Information (GPSR)

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

• Storage: Store in a cool, dry place and protect from heat and direct sunlight.
• Package Integrity: Do not use if the individual packaging is damaged, opened or shows signs of deterioration.
• Single Use: Product for single use only. Dispose of used condoms in household waste. Do not flush in the toilet.
• Expiry: Do not use after the date printed on the outer packaging or individual foil.
• Instructions: Carefully read the instructions before use.
• Protection Notice: No contraceptive can provide 100% protection against pregnancy, HIV or other sexually transmitted infections (STIs).
• Additional Lubricants: If additional lubricant is used, ensure it is compatible with latex condoms. Avoid oil-based lubricants.

Material Information

UNIQ condoms are made from natural rubber latex. If you have a known or suspected allergy to latex, consult a healthcare professional before use.

Medical Device Certification

CE Marking – compliant with EU medical device regulations.

Notified Body: 0482 – DNV MEDCERT GmbH
Pilatuspool 2, 20355 Hamburg, Germany
Website: www.medcert.de | Email: medcert-info@dnv.com

Responsible Economic Operators

Manufacturer:
UNIQUE International S.A.S. (CO-MF-000018348)
Cra 19A No. 196-23, Bogotá, Colombia
Website: www.uniqcondoms.com | Email: info@uniqcondoms.com

EU Authorized Representative:
MDI Europe GmbH (DE-AR-000006218)
Langenhagener Str. 71, 30855 Langenhagen, Germany
Website: www.mdi-europa.com | Email: info@mdi-europa.com

Importer:
Adloran GmbH (DE-IM-000012871)
Gewerbegebiet 5, 06577 An der Schmücke, Germany
Website: www.adloran.com | Email: post@adloran.com

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