RICHTER RUBBER TECHNOLOGY SDN. BHD.

Richter Rubber Technology Sdn. Bhd. specializes in basic male condoms made from Hevea-latex. These devices are primarily designed for contraception and protection against sexually transmitted infections. The company’s portfolio includes multiple variants under the Primeros brand and a separate line called Inspire, all falling under the category of barrier contraceptives.

The company is headquartered in Malaysia, where it operates as a manufacturer of latex-based medical devices. Its location in Malaysia influences regulatory compliance requirements, particularly for devices marketed in regions like the EU and the US.

Richter Rubber Technology’s devices are recorded in two key regulatory databases: EUDAMED (the European Union’s medical device registry) and the FDA’s UDI system (Unique Device Identifier database in the United States). These registries track device information for transparency and compliance purposes, ensuring traceability across markets.

The company’s products are classified as Class II or Class IIa/IIb medical devices. This classification is determined by factors like the risk associated with the device’s use (e.g., contraception and STI protection) and its intended purpose. Class II devices typically require additional controls beyond general good manufacturing practices to ensure safety and performance.