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Karex Industries Sdn. Bhd.

Active in EUDAMED

Malaysiafrom SRN EUDAMED SRN MY-MF-000001247

Devices
530
Registrations
EUDAMED

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.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue530

Newest first, rows 501-530 of 530

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  • BIRR Sterile Probe Cover (KX07) Ref LPC33SD

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • TOP Standard Ref 11022

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Unisens Ref C1530DBEVF (Aloe Vera)

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Loovara Fox Ref P53S FXUT

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • TOP Red Ref 11029

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • TOP Lovers Mix Ref 11051

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Confortex Nature Ref XXSH48010

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Happy Sex Sensitive Ref P53S XUT

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Protective Transducer Cover Ref KX06

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • MyOne Ref P64S - O22 (64G) XN5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • TOP Super Dot Ref 11040

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • MyONE® Custom Fit™ Ref MY-51G-312

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Intimy Taille XL Ref P56S

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIb

  • Durex Originals XXL Ref 3321777

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIb

  • MySecretCondom Ref 10001S2391

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Pasante Glow Ref R1230K

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIb

  • MyONE® Custom Fit™ Ref MY-55E-336

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • SOFT Space XL Ref CS-018-21

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Tynn Ref P53S XUT

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Loovara Buffalo Ref P64S-FXN5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Intimy Taille XXL Ref P60S

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIb

  • MyONE® Custom Fit™ Ref MY-57F-336

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Soft Tutti Frutti Ref CS-018-28

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIb

  • MyOne Ref P69S - N31 (69H) XN5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • MyOne Ref P53S - S99 (53E) XUT

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • TOP Red Ref 11028

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • MyONE® Custom Fit™ Ref MY-55H-312

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Preservatif Masculin Extra Large Ref P56S

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIb

  • MyOne Ref P69S - N31 (69H) XN5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Soft Extra Sensation Ref CS-018-84

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

Rows 501-530 of 530

Showing 501-530 of 530

Company details

EUDAMED SRN
MY-MF-000001247
EUDAMED status
Active
EUDAMED registered name
Karex Industries Sdn. Bhd.
EUDAMED abbreviated name
KISB
Registered address
PTD 7906 & 7907, Taman Pontian Jaya,, 82000, Pontian, Johor, Malaysia
Phone
+6 03 3165 6688
PRRC contact
Khairunnisa Warsito(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 2 Aug 2028

EUDAMED certificates (1)

TÜV SÜD Product Service GmbH 0123 1 certificate

  • G10 102558 0008 Active

    Quality management system EU MDR

    Issued
    3 Aug 2023
    Expires
    2 Aug 2028

From the company website

Read 18 Sep 2026

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