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.
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.