UKCA / CE Conformity

Tiny Air is a Class I medical device for automated pre-cleaning of surgical instruments before processing in a washer disinfector. It is marked for sale in the United Kingdom (UKCA) and the European Union (CE), and may be used in Sterile Services departments or at point of use.

DTAC

The Tiny Air Pre-clean is a UKCA/CE-marked class 1 medical device. The machine records operational and validation data for device traceability and maintenance purposes. It does not connect to NHS clinical networks, does not process patient-identifiable information, and the remote support functionality is used for technical support. Therefore, we do not believe the device falls within the primary scope of DTAC, although we can provide cyber-security, data-flow and remote-access assurance documentation if required.

For regulatory or procurement enquiries, please contact us.