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Karex Industries Sdn. Bhd.

Manufacturer of medical devices registered in the European database in Pontian, Johor, Malaysia.

Registration number (SRN)MY-MF-000001247
Short nameKISB
RoleManufacturer
StatusActive
CountryMalaysia
City82000 Pontian, Johor
AddressPTD 7906 & 7907, Taman Pontian Jaya, , 82000 Pontian, Johor
Registered on2021-02-08

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entryKAREX INDUSTRIES SDN BHD (MY) · FDA 9680135

Notified body certificates

CertificateStatusExpiryTypeBody
G10 102558 0008valid2028-08-02Quality management systemNB 0123

⚠️ State of the register on 2026-08-20. EUDAMED shows only the current version of a certificate — earlier versions are not published, by the Commission or by anyone. A certificate shown as valid here may have changed since. For a legally binding check, consult EUDAMED directly.

The SRN is the registration number assigned by the European Commission. It has been mandatory since 28 May 2026 for any operator placing a medical device on the Union market. Contact details are published in the official register; we do not reproduce them here.

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