Innolatex Sdn. Bhd.

Innolatex Sdn. Bhd. specializes in condoms, offering a variety of styles including flavored options like banana and vanilla, ultra-thin variants, ribbed designs, and larger-sized or textured variants. Their portfolio also includes a multi-functional condom combining multiple features. These products are designed to cater to diverse user preferences.

Innolatex Sdn. Bhd. is based in Malaysia. The company’s location is relevant for understanding its regulatory framework and manufacturing operations, particularly for compliance with regional standards.

Innolatex Sdn. Bhd.’s devices are classified under the EU Medical Device Regulation as Class II and Class IIb. This classification determines the regulatory requirements for their design, manufacturing, and post-market surveillance, with Class IIb indicating a higher risk profile than Class II.

Yes, Innolatex Sdn. Bhd.’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry, and in the FDA’s 510(k) registry, which is used for premarket notifications in the United States. These listings provide transparency on authorized devices and their regulatory status.