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Product Safety and Regulatory Compliance – SKYN Condoms
Material Information – Latex-Free
SKYN condoms are made from SKYNFEEL® material (synthetic polyisoprene). They do not contain natural rubber latex and are suitable for people with confirmed or suspected latex sensitivity or allergy.
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 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:
SURETEX Ltd
31/1 Moo 4, Suratthani-Thakuapha Road, Tambon Khao Hua Kwai,
Amphur Phunphin, Suratthani 84130, Thailand
Email: quality.europe@lifestyles.com
EU Authorized Representative / Importer:
SXWell Belgium bvba
Lenniksebaan 451/35, 1070 Anderlecht, Belgium