BIOMAX RUBBER INDUSTRIES SDN BHD

BIOMAX Rubber Industries SDN BHD manufactures disposable latex gloves under the brand name Galenika. These gloves are intended for single-use applications, offering barrier protection in both medical and industrial environments. The focus is solely on latex-based disposable gloves, which are classified as medical devices when used in healthcare settings.

The company is headquartered in Malaysia, where it operates as a manufacturer of disposable latex gloves. Its location in Malaysia influences its regulatory compliance requirements, particularly if its products are distributed internationally.

Yes, BIOMAX Rubber Industries SDN BHD’s disposable latex gloves are registered in the EU’s eudamed database. This registry is used to track medical devices placed on the European market, ensuring transparency and traceability for regulatory oversight.

Under EU medical device regulations, BIOMAX Rubber Industries SDN BHD’s disposable latex gloves fall under Class I. This classification applies to low-risk devices like single-use gloves, which typically require less stringent regulatory scrutiny compared to higher-risk categories.