UMONIUM38® Neutralis - Detergent–Disinfectant · CE IIb Medical Device

UMONIUM38® Neutralis is a broad-spectrum, high-level detergent-disinfectant developed by Laboratoire Huckert's International (Belgium) for use in grade 3 and grade 4 pharmaceutical and biotech manufacturing environments, cleanrooms and laboratories. It is CE marked as a Class IIb medical device under EU MDR 2017/745.

The formulation combines a quaternary ammonium active (isopropyl-tridecyl-dimethyl-ammonium) with a surfactant carrier, giving it bactericidal, mycobactericidal, fungicidal and virucidal activity validated to EN standards, at low use concentrations and short contact times. It is pH neutral, non-corrosive, non-flammable, biodegradable, and free of CMR components and endocrine disruptors.

Manufactured under ISO 9001 and ISO 13485 quality systems, with documentation intended to support customers' own EU GMP Annex 1 contamination control strategies. Mitrone Healthcare is the exclusive Irish distributor, holding local stock and handling HPRA-facing distributor and vigilance obligations.

• CE Class IIb medical device (EU MDR 2017/745)
• Bactericidal, mycobactericidal, fungicidal, virucidal activity (EN standards, product-specific)
• No CMR components or endocrine disruptors, pH neutral, non-flammable, biodegradable
• Manufactured under ISO 9001 and ISO 13485
• Companion products in the range: UMONIUM38® Instruments and UMONIUM38® Sterily, for instrument pre-disinfection and disinfection

Full validation dossier, safety data sheet and CE declaration of conformity available on request.