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Product Safety and Regulatory Compliance – Sagami 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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Storage: Store in a cool, dry place, away 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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Instructions: Carefully read the instructions before use.
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Expiry: Do not use the condom after the date printed on the outer packaging or the foil.
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Protection Notice: No contraceptive can offer 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. Avoid oil-based lubricants.
Material Information – Latex-Free
Sagami condoms are made from polyurethane — an ultra-thin synthetic material. They do not contain natural rubber latex and are suitable for people with confirmed or suspected latex sensitivity or 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
Website: www.de.tuv.com |
Email: medical-products@de.tuv.com
Responsible Economic Operators
Manufacturer:
Sagami Manufacturers Sdn. Bhd. (MY-MF-000039689)
Plot 29, Lorong Bemban 4, Estet Perindustrian Bemban, Jalan Bemban,
31000 Batu Gajah, Malaysia
Website: sagami-gomu.co.jp |
Email: qa-usagami@sagami-mf.com
EU Authorized Representative:
Sagami Europe SARL (FR-AR-000038926)
12c Rue du Château, Château de Brugheas, 03700 Brugheas SIREN, France
Website: www.sagami-europe.com |
Email: admin@sagami-europe.com
Importer:
Adloran GmbH (DE-IM-00012871)
Gewerbegebiet 5, 06577 An der Schmücke, Germany
Website: www.adloran.com |
Email: post@adloran.de
* Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety, amending Regulation (EU) No 1025/2012 and Directive (EU) 2020/1828, and repealing Directive 2001/95/EC and Council Directive 87/357/EEC.