Romsons International (Unit II)

Romsons International specialises in respiratory and drainage devices. Their portfolio includes tracheostomy tubes (both cuffed and plain), suction connecting tubes, chest drainage catheters, and oxygen delivery systems like the Oxy Set. They also produce intravenous and micron infusion catheters, such as the Vein-O-Line and Flexo Cath, catering to critical care and patient monitoring needs.

Romsons International is based in India, as indicated by its country of origin. The company’s manufacturing and operations are conducted within this region.

Several of Romsons International’s devices are listed in the eudamed registry, which is the EU’s centralised database for medical devices. This registry tracks devices authorised for placement on the European market, ensuring transparency and traceability.

Romsons International’s devices fall under Class I and Class IIa classifications. Class I devices are generally low-risk, such as simple catheters or drainage tubes, while Class IIa devices involve a moderate level of risk, often requiring additional safety measures or performance standards, like certain tracheostomy tubes or specialised infusion systems.