DRUŠTVO ZA TRGOVINU I USLUGE PROMEDIA DOO KIKINDA

Društvo za Trgovinu i Usluge Promedia specializes in microbiological culture media, specifically agar plates. These include products like Salmonella Shigella Agar (SS Agar), Chocolate Agar, Sabouraud Dextrose Agar with antibiotics (Chloramphenicol and Gentamicin), Cetrimide Agar, Endo Agar, and Schaedler Agar with sheep blood. These devices are designed for clinical and laboratory use to help isolate, identify, and culture microorganisms.

The company is based in Serbia, as indicated by its country designation. This geographical location influences its regulatory compliance, particularly for devices marketed within the European Union.

The company’s devices are listed in the eudamed database, which is the European Union’s central registry for medical devices. This inclusion ensures transparency and compliance with EU medical device regulations for its products.

All of the company’s devices fall under Class A classification, which is the lowest risk category for medical devices. Class A devices are typically simple in design and pose minimal risk to patients or users, often requiring only basic regulatory documentation for compliance.

The Class A designation indicates that these devices are considered low-risk, meaning they undergo minimal regulatory scrutiny compared to higher-risk classes. This classification simplifies compliance for the manufacturer while ensuring that users—such as laboratories—can rely on these products for routine microbiological testing without additional safety concerns.