Product Safety and Regulatory Compliance – Okamoto Condoms
Material Information
Okamoto condoms are manufactured to high quality and safety standards. Please refer to the individual product packaging for specific material and product details.
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.
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Storage: Store in a cool, dry place, away from heat and direct sunlight. -
Package Integrity: Do not use if the individual foil or outer 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. -
Instructions: Carefully read the instructions before use. -
Protection Notice: No method of contraception provides 100% protection against pregnancy, HIV or other sexually transmitted infections (STIs). - Additional Lubricants: If additional lubricant is used, ensure it is specifically labeled as safe for use with condoms.
Medical Device Certification
CE Marking – compliant with EU medical device regulations.
Notified Body: 2797 – BSI Group The Netherlands B.V.
Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, Netherlands.
Responsible Economic Operators
Manufacturer:
Okamoto Industries Inc.
3-27-12 Hongo, Bunkyo-ku, Tokyo 113-8710, Japan
Contact: quality.europe@lifestyles.com
EU Authorized Representative:
SXWell Belgium bvba
Lenniksebaan 451/35, 1070 Anderlecht, Belgium
EU Regulatory Reference:
Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety.