Medical device decontamination agent

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

In Vitro Technologies Pty Ltd

Class:

Class I

Manufactured by:

Medisafe UK Ltd Units 7 & 8 Stortford Hall Industrial Park Dunmow Road, Bishop's Stortford, Hertfordshire, CM23 5GZ United Kingdom

Therapeutic area:

63385 - Medical device cleaning agent

Therapeutic indications:

A kit containing components intended to pre soak reusable complex medical/surgical instruments (such as robotic instruments, endoscopes) immediately after use. One such component is a substance with several enzymatic ingredients (e.g. protease, amylase, lipase, carbohydrase) as its active agents to remove organic matter (e.g. blood, mucus, faeces) from the instruments prior to sterilisation. After application, this device cannot be reused.

Authorization status:

A

Authorization date:

2014-06-23