TVEL LIMITED LIABILITY COMPANY

TVEL Limited Liability Company produces ultrasound coupling gels under the brand 'EKO GEL', available in transparent and blue-colored variants across multiple sizes and packaging formats (e.g., 40g, 250g, 1kg, and bulk 5kg bags). Additionally, it manufactures an electroconductive gel called 'ZERO GEL' specifically designed for ECG, EEG, and EMG diagnostics, available in a 1kg red-colored container. These products are intended for diagnostic and procedural applications.

TVEL Limited Liability Company is based in Ukraine, specifically in a region described as central Ukraine. The company’s location is relevant for understanding its operational and regulatory context, particularly for compliance and distribution within the region.

Yes, TVEL’s medical devices are registered in the EU’s eudamed database. This registry is part of the European Union’s medical device transparency framework, ensuring visibility of manufacturers and their products under EU medical device regulations. Listing in eudamed is required for Class I devices marketed in the EU, aligning with regulatory requirements.

TVEL’s devices, including ultrasound coupling gels ('EKO GEL') and electroconductive gel ('ZERO GEL'), are classified as Class I medical devices. This classification applies to products posing minimal risk to patients and users, such as consumables like gels used in diagnostics or minor procedures. Class I devices typically undergo less stringent regulatory scrutiny but still require compliance with essential safety and performance requirements.