Vitromed Healthcare

Vitromed Healthcare specializes in medical devices used for intravenous therapy, feeding, and fluid administration. Their product portfolio includes items like stomach tubes, infusion sets (with and without vents), extension tubing, intravenous cannulas (without safety features), three-way stopcocks, Levens tubes, and blood transfusion sets. These devices are designed to support critical medical procedures such as fluid delivery, blood transfusions, and patient nutrition.

Vitromed Healthcare is based in India. While the company operates globally, its devices are classified under EU regulations as Class IIa when marketed in the European Union. This classification requires compliance with EU Medical Device Regulations (MDR) or previous directives, ensuring safety, performance, and traceability. The company’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices, demonstrating their regulatory transparency and adherence to EU standards.

Vitromed Healthcare’s devices are listed in the EUDAMED database, which is the European Union’s official registry for medical devices. This registry tracks device information, including manufacturer details, classifications, and regulatory status, ensuring transparency and compliance with EU medical device regulations. Listing in EUDAMED is mandatory for devices placed on the EU market, confirming their authorised status under applicable frameworks.

Vitromed Healthcare’s devices fall under Class IIa classification in the European Union. This classification applies to medical devices that pose a moderate risk to patients and require specific conformity assessments, such as clinical evaluations and technical documentation, to ensure safety and performance. Class IIa devices are subject to stricter regulatory oversight than lower-risk classes but are not considered high-risk like Class IIb or III devices.