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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 451-500 of 530

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  • Fair Square Ultimate Thin Ref P53S FXST

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Gyneas Probe Cover Ref CS-018-06-PC

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

  • Loovara Eagle Ref P47S

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • SOFT Rider Ref P53S

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

  • INTIMY Multipack Mix Plaisir Ref 096581-ETUIFT2252

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • MyOne Ref P69S - O31 (69G) XN5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Mister Size 47 Ref P47S XUT

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Intimy Extase Ref P52GS

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

  • MyOne Ref P64S - Z22 (64K) XN5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • MyONE® Custom Fit™ Ref MY-64K-336

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Happy Sex Sensitive Ref 021

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Durex (France) Comfort XXL Ref 3117736

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Cefem Slimfit Ref SF145

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Mister Size 64 Ref P64S 64L XN5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • MyOne Ref P69S - G31 (69M) XN5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Mister Size 69 Ref P69S 69L XN5

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

  • Amarelle Xtra Ref P53S-ES

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Cefem Ung.no Ref UNG145

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

  • Mister Size 53 Ref BULKMS53100

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • INTIMY Fins Ref 096074-ETUIFT2245

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • SOFT Tutti Frutti Ref P53S

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Cefem Tynn Ref TYNBE

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • SOFT Classic Natural Ref P53S

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

  • MyOne Ref P49S - E77 (49C) XUT

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Let's Uzun Gece Ref CS-200-01

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Mister Size 64 Ref MS6436

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • MyONE® Custom Fit™ Ref MY-51E-312

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • TOP Standard Ref 11021

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Amed Ref KX07

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • MyOne Ref P69S - Z31 (69K) XN5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Soft Nature Ref C1530DBEV

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Carex Classic Ref P53S

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Jacket Ref KX07

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • INTIMY Classic Ref 196070- ETUIBT0540

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Mister Size 53 Ref MS5336

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • MyOne Ref P51S - N88 (51H) XUT

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Preservatif Masculin Ref 620249

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Soft Ref KX07

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Medline KX06 Sterile, Unlubricated Ref ICE28295P

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

  • Medline Ref KX07

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

  • MyOne Ref P64S - S22 (64E) XN5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • TOP Standard Ref 11020

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Cahnos Ref KX07

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Mister Size 49 Ref P49S XUT

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Intimy Phospho Love Light Glow Ref P53S

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • LOVE Sensitive Ref P53S XUT

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • TOP Ultimate Thin Ref 11041

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • MyOne Ref P60S - O21 (60G) XUT

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Durex Perfect Connection Ref 3309663

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

  • Gyneas Ref 12.206

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

Rows 451-500 of 530

Showing 451-500 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