Karex Industries Sdn. Bhd.
Active in EUDAMEDMalaysiafrom SRN EUDAMED SRN MY-MF-000001247
- Devices
- 530
- Registrations
- EUDAMED
Catalogue
MyONE® Custom Fit™ Ref MY-55G-312
TOP Strong Ref K-CS-254-38
TOP Ribbed & Dots Ref 11043
MyONE® Custom Fit™ Ref MY-57J-312
MyOne Ref P49S - B77 (49D) XUT
MyONE® Custom Fit™ Ref MY-49D-312
TOP Standard Ref 11019
Non-latex Endo Probe Cover KX-06NL Ref KX-06NL
Wiwitex Aqua Gel Ref C1530DBEV
MEDIWARE Non-Sterile, Unlubricated KX07 Ref H5 1340
Mister Size Size 57 Ref BULK571000MS
Soft Invisible Ref CS-018-80
MyONE® Custom Fit™ Ref MY-45E-336
Klassisk Ref P53S
Durex (Poland) Perfect Gliss Ref P56S
Confortex Fresa Ref P53S
MyOne Ref P51S - S88 (51E) XUT
Intimy Stimulate Ref C53RS-S
Protégé sondes Ref KX07
Fair Squared Max Perform Ref 4719650
Mister Size Size 53 Ref MS5303
Happy Sex Sensitive Ref 030
Krystal KX07 Probe Cover Ref 102.0027 Ref Ref 102.0027
MyOne Ref P60S - N21 (60H) XUT
MyONE® Custom Fit™ Ref MY-53D-336
MyONE® Custom Fit™ Ref MY-45C-312
UNIDIX Non-Sterile, Unlubricated KX 07 Ref 41005020100
MEDLINE Non-Sterile, Unlubricated KX 07 Ref NS-ICE33230L
144 Male Condoms Ref 4002460
MyONE® Custom Fit™ Ref MY-45D-336
Durex (Spain) Natural XL Ref 3130092
EDM Medical Imaging Ref KX06
Kondom Xtra Large Ref P56S
Jordbaer Ref P53S XUT
Best Scan Ref KX04
MyOne Ref P57S - N17 (57H) XUT
Durex (Italy) 3XL Ref P64S
MyONE® Custom Fit™ Ref MY-69K-312
ONE® Flavor-Waves™ Ref 110232
MyOne Ref P60S - U21 (60L) XUT
MyOne Ref P51S - O88 (51G) XUT
MyONE® Custom Fit™ Ref MY-55J-312
CAHNOS Non-Sterile, Unlubricated KX 07 Ref 0000575
MyOne Ref P47S- M66 (47F) XUT
Curamor Extra Feucht Ref 4930102
Amarelle Lube Strawberry Ref 4719984
Fair Squared Sensitive Dry Ref 4000017
INTIMY Classic Ref 096071-ETUIFT2242
SOFT Vanille Ref P53S
TOP Red Ref 11027
Showing 151-200 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
- Website
- www.karex.com.my
- [email protected]
- Phone
- +6 03 3165 6688
- PRRC contact
- Khairunnisa Warsito
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 2 Aug 2028
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
From the company website
Karex, World’s Largest Condom Maker, is a listed company on the Main Market of Bursa Malaysia Securities Berhad.
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.