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Medical devices and IVDs: Cancellations from the ARTG

22 June 2021

Following a review by the TGA, medical device entries (including IVDs) can be cancelled from the Australian Register of Therapeutic Goods. These cancellations are made by the Secretary under section 41GK, 41GL, 41GM and 41GN of the Therapeutic Goods Act 1989.

Where other actions are taken in relation to safety, the TGA will generally publish additional information about the issue on its alerts page.

The reasons for a cancellation are stated in the database below under 'Grounds for cancellation'.

The heading 'Decision status' provides updated information about cancellation decisions, for example information about any decision to revoke a cancellation decision. It will not appear in every entry.

To find out whether a product is currently authorised for supply in Australia, check the ARTG.

For cancellations that result in only one or more medical devices of a kind being cancelled and not the entry removed from the ARTG, see:

For cancellations of face masks following post-market review, see: Post-market review of face masks: Cancelled ARTG entries

Medical devices and IVD cancellations

Displaying 51 - 75 of 515

2021

Date of effect: 5 Mar 2021

TOWARDS GROUP HOLDING PTY LTD

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 339997

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(1)(c) of the Act.

Failure to comply with s41JA within a further 10 days

Date of effect: 5 Mar 2021

TOWARDS GROUP HOLDING PTY LTD

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 341718

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(1)(c) of the Act.

Failure to comply with s41JA within a further 10 days

Date of effect: 5 Mar 2021

KCM Hygiene Pty Ltd

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 325345

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(1)(c) of the Act.

Failure to comply with s41JA within a further 10 days

Date of effect: 4 Mar 2021

BlueMountain Healthcare Pty Ltd

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 335361

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(1)(c), (f) and 41FD(d) of the Act.

Failure to comply with s41JA within a further 10 days, poor device safety and incorrect certification

Date of effect: 4 Mar 2021

Face mask Edit

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 341399

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 1 Mar 2021

ENVIRO TECH HOLDING PTY LTD

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 341652

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 1 Mar 2021

ENVIRO TECH HOLDING PTY LTD

Product name/ARTG reference: Public respirator, single-use

ARTG number: 345617

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 22 Feb 2021

Son Loc Melbourne Pty Ltd

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 340322

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 22 Feb 2021

W H Safety Pty Ltd

Product name/ARTG reference: Public respirator, single-use

ARTG number: 341630

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 22 Feb 2021

The Trustee for DKT Family Trust

Product name/ARTG reference: Surgical/medical respirator, single-use

ARTG number: 340030

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 22 Feb 2021

Hannah Haniel Pty Ltd

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 332847

Type of regulatory action: Cancellation from the ARTG under subsection 41GN(1) of the Act.

Failure to comply with a condition of inclusion and a certification made under 41FD is incorrect in a material particular

Date of effect: 22 Feb 2021

Eco Corporation

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 341643

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 22 Feb 2021

Siddiqui Bros Pty Ltd

Product name/ARTG reference: Airway protection face mask

ARTG number: 341472

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 19 Feb 2021

Peng United Star Pty Ltd

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 340880

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 19 Feb 2021

Peng United Star Pty Ltd

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 340881

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 19 Feb 2021

MHYGIENE PTY LTD

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 340836

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 19 Feb 2021

Rhodes & Beckett Trading Pty Ltd

Product name/ARTG reference: Mask, <specify>

ARTG number: 341029

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 19 Feb 2021

Medsupply Australia Pty Ltd

Product name/ARTG reference: Mask, <specify>

ARTG number: 340638

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 19 Feb 2021

Game on Product Group Pty Ltd

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 340979

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 19 Feb 2021

Peng United Star Pty Ltd

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 339970

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 18 Feb 2021

Max Rich Pty Ltd

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 340113

Type of regulatory action: ancellation from the ARTG under subsection 41GM(1) of the Act

Non response to a s41JA

Date of effect: 18 Feb 2021

Lohas Holding Pty Ltd

Product name/ARTG reference: Public respirator, single-use

ARTG number: 340805

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 18 Feb 2021

Eveda AusNZ Pty Ltd

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 340500

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 18 Feb 2021

Better Health Pharmacy Pty Ltd

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 341453

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

Date of effect: 18 Feb 2021

Better Health Pharmacy Pty Ltd

Product name/ARTG reference: Mask, surgical, single use

ARTG number: 341462

Type of regulatory action: Cancellation from the ARTG under subsection 41GM(1) of the Act.

Non response to a s41JA

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