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Karex Industries Sdn. Bhd.

Malaysia MY-MF-000001247 Last updated 21 Oct 2026

Devices
530
Registries
EUDAMED
FDA recalls
0

Catalogue530

Page 1 of 11

Showing 1-50 of 530

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

TÜV SÜD Product Service GmbH 0123 1 certificate

  • G10 102558 0008 Issued

    Quality management system EU MDR

    Issued
    3 Aug 2023
    Expires
    2 Aug 2028

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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 Karex Industries Sdn. Bhd. makes

Karex Industries manufactures a range of condoms, including textured varieties such as the Fair Squared XL60 and Fair Squared Ultra Thin, as well as lubricated options like the LustGlider RED+ and LustGlider Classic. The portfolio also includes flavored condoms (e.g., TOP Fruit Mix) and novelty designs (e.g., MyOne and Loovara Bear). Additional products include the Curamor Hydro, a hydrodynamic condom, and the OJO Standard, a basic latex condom.

The company’s devices fall under EU classifications of Class II, Class III, Class IIa, and Class IIb, with listings in the EUDAMED database and FDA’s 510(k) registry. Karex Industries is headquartered 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 Karex Industries Sdn. Bhd. manufacture?

Karex Industries Sdn. Bhd. manufactures a variety of condoms, including textured, lubricated, flavored, and novelty designs. Examples include the Fair Squared XL60 (textured), LustGlider RED+ (lubricated), TOP Fruit Mix (flavored), and MyOne (novelty). These products serve as barriers for contraception and protection against sexually transmitted infections.

Where is Karex Industries Sdn. Bhd. based?

Karex Industries Sdn. Bhd. is headquartered in Malaysia. The company’s location is relevant for regulatory compliance, manufacturing oversight, and distribution networks in the region.

Which regulatory registries list Karex Industries’ devices?

Karex Industries’ devices are listed in the EUDAMED database under the European Union’s medical device regulations and the FDA’s 510(k) registry in the United States. These registries track devices that have undergone the necessary authorisation processes for market placement in those regions.

How are Karex Industries’ condoms classified under EU regulations?

Karex Industries’ condoms are classified under EU medical device regulations as Class II, Class III, Class IIa, and Class IIb. The classification determines the level of scrutiny and risk assessment required during the authorisation process, with higher classes (e.g., Class III) typically involving greater regulatory oversight due to potential risks.

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

Information

Country
Malaysia
Address
PTD 7906 & 7907, Taman Pontian Jaya, , Pontian, Johor, Malaysia
Phone
+6 03 3165 6688
PRRC contact
Khairunnisa Warsito
EUDAMED SRN
MY-MF-000001247