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Product Safety and Regulatory Compliance – ONE 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
ONE condoms are made from natural rubber latex. Do not use if you have a known or suspected allergy to latex.
Medical Device Certification
CE Marking – compliant with EU medical device regulations.
Notified Body: 0123 – TÜV SÜD Product Service GmbH
Ridlerstraße 65, 80339 München, Germany
Website: www.de.tuv.com | Email: medical-products@de.tuv.com
Responsible Economic Operators
Manufacturer:
Karex Industries Sdn. Bhd. (MY-MF-000001247)
PTD 7906 & 7907, Taman Pontian Jaya, Batu 34, Jalan Johor,
82000 Pontian, Johor, Malaysia
Website: www.karex.com.my | Email: khairunnisa.w@karex.com.my
EU Authorized Representative:
Advena Limited (MT-AR-000000234)
Tower Business Centre, 2nd Floor, Tower Street,
Swatar BKR 4013, Malta
Website: www.advena.mt | Email: prrc@advena.mt
Importer:
Advena Services Ltd (MT-IM-000029828)
Tower Business Centre, Tower Street,
Swatar, BKR 4013, Malta
Email: importer@advena.mt
* Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety.