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Product Safety and Regulatory Compliance – Pasante Female Condoms
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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Latex-Free: This product does not contain natural rubber latex and is suitable for people with latex allergy or sensitivity.
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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 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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Instructions: Carefully read the instructions before use.
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Protection Notice: No method of contraception provides 100% protection against pregnancy or sexually transmitted infections (STIs).
- Additional Lubricants: If additional lubricant is used, ensure it is compatible with the material of the condom.
Material Information – Latex-Free
Pasante female condoms are made from a synthetic latex-free material. They do not contain natural rubber latex and are suitable for individuals with confirmed or suspected latex allergy.
Medical Device Certification
CE Marking – compliant with EU medical device regulations.
Notified Body: 0123 – TÜV SÜD Product Service GmbH
Ridlerstraße 65, 80339 München, Germany.
Responsible Economic Operators
Manufacturer:
The Female Health Company (UK) Plc (GB-MF-000029355)
3 Mansfield Road, Western Avenue Business Park, London, W3 0BZ, United Kingdom
Website: fc2femalecondom.com
Email: info@fc2femalecondom.com
E.U. Representative:
Advena Limited (MT-AR-000000234)
Tower Street, Tower Business Centre, 2nd Flr., Swatar BKR4013, Malta
Email: prcv@advena.mt
Importer:
Advena Services Ltd (MT-IM-000029828)
Tower Business Centre, 2nd Floor, Tower Street, Swatar, BKR 4013, Malta
Email: importer@advena.mt
EU Regulatory Reference:
Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety.