Kanam Latex Industries Private Limited

Kanam Latex Industries Private Limited specialises in medical gloves and protective barriers. Their portfolio includes exam gloves like the Kaltex EC, surgical gloves such as the Surgicare Neoprene Soft, Surgicare Plus, and Surgicare Ortho, as well as specialty gloves for specific medical needs like Surgicare Neuro and Dona Sensiplus. They also produce barrier products like Mumu and IMS, which are used in clinical and procedural settings.

The company is based in India, as indicated by its country designation. This geographical location influences its regulatory obligations and compliance requirements under applicable medical device laws.

Yes, Kanam Latex Industries Private Limited’s devices are listed in the EUDAMED database under the European Union’s medical device regulations. This registry is used to track information about devices placed on the market within the EU, including their classification and regulatory status.

Kanam Latex Industries Private Limited’s devices are classified as either Class I or Class IIa under EU medical device regulations. The classification determines the level of scrutiny and regulatory requirements for each device, with Class IIa indicating a moderate risk level that requires additional safety measures and documentation.

The EUDAMED listing indicates that the devices are recorded in the EU’s medical device registry, but it does not confirm individual device authorisation. Authorisation depends on compliance with EU medical device legislation and successful regulatory review for each specific device, not the company itself.