Product Safety and Regulatory Compliance – Durex Condoms
General Safety and Usage Information (GPSR)
This product is a medical device. Use it according to the instructions provided on the packaging.
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Storage: Store in a cool, dry place and protect from heat and direct sunlight.
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Package Integrity: Do not use if the individual packaging is damaged, opened or shows signs of deterioration.
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Single Use: Product for single use only. Dispose of used condoms in household waste. Do not flush in the toilet.
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Expiry: Do not use after the date printed on the outer packaging or individual foil.
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Instructions: Carefully read the instructions before use.
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Protection Notice: No contraceptive can provide 100% protection against pregnancy, HIV or other sexually transmitted infections (STIs).
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Additional Lubricants: If additional lubricant is used, make sure to only use condom-safe products. Avoid oil-based lubricants.
Material Information
Durex condoms are made from natural rubber latex. Do not use if you have a known or suspected allergy to latex or if your skin is sensitive to contact with latex.
Medical Device Certification
CE Marking – compliant with EU medical device regulations.
Notified Body: 1639 – SGS Belgium NV
SGS House, Noorderlaan 87, Antwerpen 2030, Belgium
Website: www.sgs.com |
Email: info@sgs.com
Responsible Economic Operators
Manufacturer:
Reckitt Benckiser Healthcare (UK) Ltd (GB-MF-000035615)
Dansom Lane, Hull, HU8 7DS, East Yorkshire, United Kingdom
Website: www.reckitt.com
Email: GRAMedicalDevices@reckitt.com
EU Authorized Representative:
RB NL Brands B.V. (NL-AR-000006055)
Schiphol Bvd 207, 1118 BH Schiphol, Netherlands
Website: www.reckitt.com
Email: GRAMedicalDevices@reckitt.com
Importer:
Reckitt Benckiser Healthcare B.V. (BE-IM-000040224)
Researchdreef 20, 1070 Brussel, Belgium
Website: www.reckitt.com
Email: regulatory.affairs@reckitt.com
* Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety.
