REM Systems Pty Ltd

Infusion pump, syringe (T34L Models only) (Cancellation from the ARTG under subsection 41GM(2) of the Act. Cancellation will be limited to some medical devices of the kind (only T34L, T34L NeoFeed and T34L KID models) and the ARTG must be varied according

8 September 2020

Cancellation or suspension

Regulatory action due to The response from a Section 41JA notification has informed that the device type is not supplied or imported in Australia, or exported from Australia.The grounds for cancellation apply only to T34L variants of infusion pumps (including T34L, T34L NeoFeed and T34L KID models) and the cancellation is limited under s41GO to vary ARTG 131232 accordingly., effective 08/09/2020

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REM Systems Pty Ltd

Infusion pump, syringe (T34L Models only) (Cancellation from the ARTG under subsection 41GM(2) of the Act. Cancellation will be limited to some medical devices of the kind (only T34L, T34L NeoFeed and T34L KID models) and the ARTG must be varied according

REM Systems Pty Ltd - Label/tag, device sterility (301907)

REM SYSTEMS PTY LTD - Unclassified Cancelled under Section 41GL(d) of the Act

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REM Systems Pty Ltd - Laryngoscope, rigid Cancelled under Section 41GL(d) of the Act

REM Systems Pty Ltd - Laryngoscope, rigid Cancelled under Section 41GL(d) of the Act

REM Systems Pty Ltd - Catheter-introduction needle Cancelled under Section 41GL(d) of the Act

REM Systems Pty Ltd - L-Cath™ PICC Basic Kits - Catheter, central venous, peripherally inserted Cancelled under Section 41GL(d) of the Act

REM Systems Pty Ltd - First PICC™ Catheter - Catheter, central venous, peripherally inserted Cancelled under Section 41GL(d) of the Act

REM Systems Pty Ltd - L-Cath™ PICC - Catheter, central venous, peripherally inserted Cancelled under Section 41GL(d) of the Act

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