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Innolatex Sdn. Bhd.

Malaysia MY-MF-000001246 Last updated 21 Oct 2026

Devices
125
Registries
EUDAMEDFDA 510(k)
FDA recalls
0

Catalogue125

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About

Karex, World’s Largest Condom Maker, is a listed company on the Main Market of Bursa Malaysia Securities Berhad.

From the manufacturer's own website. Source

What Innolatex Sdn. Bhd. makes

Innolatex Sdn. Bhd. manufactures a range of condoms, including flavored varieties such as banana, vanilla, and ultra-thin options, as well as ribbed and assorted styles. Their portfolio also includes textured and larger-sized condoms, designed for varied user preferences, and a multi-functional condom combining multiple attributes.

The company’s products are classified under EU Medical Device Regulation as Class II and Class IIb devices, with listings in the EUDAMED database and FDA’s 510(k) registry. The manufacturer is based in Malaysia.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Innolatex Sdn. Bhd. manufacture?

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.

Where is Innolatex Sdn. Bhd. based?

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.

Under which EU Medical Device Regulation classes are Innolatex Sdn. Bhd.’s devices classified?

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.

Are Innolatex Sdn. Bhd.’s devices listed in any regulatory registries?

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.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Malaysia
Address
Lot 591 & 594, Persiaran Raja Lumu,, Port Klang, Selangor, Malaysia
Phone
6 03 3165 6688
PRRC contact
Ivy Wen June Ng
EUDAMED SRN
MY-MF-000001246