This page includes the latest FDA filings for Sirtex Medical Pty L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| AUSTRALIA | AUSTRALIAN STOCK EXCHANGE | SRX | DUNS 755092467 |
Sirtex Medical Pty L T D holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 9710358 |
| FEI Number | 3003428886 |
| Name | MaryLou Stroumbos |
| Owner & Operator | Sirtex Medical Pty Ltd |
| Contact Address | Shop 6 207 Pacific Highway St Leonards AU-NSW New South Wales 2065 AU |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 300 Unicorn Park Drive Woburn, MA 01801 US |
| Establishment Type | Repack or Relabel Medical Device |
| Registration Number | 3013070673 |
| FEI Number | 3013070673 |
| Name | Sirtex Germany Manufacturing GmbH |
| Owner & Operator | Sirtex Medical Pty Ltd |
| Contact Address | Shop 6 207 Pacific Highway St Leonards AU-NSW New South Wales 2065 AU |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | Industriepark Hoechst, Building G808 Frankfurt am Main, 65926 DE |
| Establishment Type |
|
| Registration Number | 3009088444 |
| FEI Number | 3009088444 |
| Name | Sirtex Singapore Manufacturing Pte Ltd |
| Owner & Operator | Sirtex Medical Pty Ltd |
| Contact Address | Shop 6 207 Pacific Highway St Leonards AU-NSW New South Wales 2065 AU |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 50 Science Park Road, #01-01 Science Park II Singapore Not Applicable, 117406 SG |
| Establishment Type |
|
| Registration Number | 3005579300 |
| FEI Number | 3005579300 |
| Name | Sirtex Wilmington LLC |
| Owner & Operator | Sirtex Medical Pty Ltd |
| Contact Address | Shop 6 207 Pacific Highway St Leonards AU-NSW New South Wales 2065 AU |
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 16 Upton Drive Unit 2-4 Wilmington, MA 01887 US |
| Establishment Type |
|
Device Company | Device | Date |
|---|---|---|
| SIRTEX MEDICAL PTY LTD | SIR-Spheres Select Y-90 resin microspheres | 2024-04-05 |
| SIRTEX MEDICAL PTY LTD | SIR-Spheres® Microspheres Activity Calculator (SMAC) | 2021-08-24 |
| SIRTEX MEDICAL PTY LTD | SIR-Spheres V-Vial | 2021-07-23 |
| SIRTEX MEDICAL PTY LTD | SIR-Spheres Accessories Pack | 2021-07-22 |
| SIRTEX MEDICAL PTY LTD | SIR-Spheres V-Vial Holder | 2021-07-22 |
| SIRTEX MEDICAL PTY LTD | SIR-Spheres Delivery Set | 2021-07-22 |
| SIRTEX MEDICAL PTY LTD | SIR-Spheres Delivery Apparatus | 2021-07-22 |
| SIRTEX MEDICAL PTY LTD | SIR-Spheres Syringe Shield | 2021-07-19 |
| SIRTEX MEDICAL PTY LTD | SIROS Delivery Set SIR-10300 | 2021-01-13 |
| SIRTEX MEDICAL PTY LTD | SIROS D-Vial Prep Set SIR-10200 | 2021-01-13 |
| SIRTEX MEDICAL PTY LTD | SIROS Delivery Dome SIR-10100 | 2021-01-13 |
| SIRTEX MEDICAL PTY LTD | SIR-Spheres microspheres SIR-Y001 | 2021-01-12 |
| Sirtex Medical Pty Ltd | SIR-Spheres microspheres | 2017-03-24 |
| Sirtex Medical Pty Ltd | SIR-SPHERES MICROSPHERES | 2017-01-18 |
| Sirtex Medical Pty Ltd | SIR-SPHERES MICROSPHERES | 2015-02-27 |
| Sirtex Medical Pty Ltd | SIR-SPHERE MICROSPHERES | 2014-10-09 |
| Sirtex Medical Pty Ltd | SIR-SPHERES | 2012-07-17 |
| Sirtex Medical Pty Ltd | SIR-SPHERES | 2008-01-18 |
Sirtex Wilmington LLC [Sirtex Medical Pty Ltd] | SIR-Spheres | 2007-10-23 |
Sirtex Wilmington LLC [Sirtex Medical Pty Ltd] | SIR-Spheres microspheres | 2007-10-23 |
Sirtex Singapore Manufacturing Pte Ltd [Sirtex Medical Pty Ltd] | SIR-Spheres | 2007-10-23 |
Sirtex Singapore Manufacturing Pte Ltd [Sirtex Medical Pty Ltd] | SIR-Spheres microspheres | 2007-10-23 |
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd] | SIR-Spheres | 2007-10-23 |
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd] | SIR-Spheres microspheres | 2007-10-23 |
Sirtex Wilmington LLC [Sirtex Medical Pty Ltd] | SIR-Spheres Delivery Box | 2003-12-19 |
Sirtex Singapore Manufacturing Pte Ltd [Sirtex Medical Pty Ltd] | SIR-Spheres Delivery Box | 2003-12-19 |
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd] | SIR-Spheres Delivery Box | 2003-12-19 |
Sirtex Wilmington LLC [Sirtex Medical Pty Ltd] | SIR-Spheres V-Vial Holder | 2003-12-19 |
Sirtex Singapore Manufacturing Pte Ltd [Sirtex Medical Pty Ltd] | SIR-Spheres V-Vial Holder | 2003-12-19 |
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd] | SIR-Spheres V-Vial Holder | 2003-12-19 |
Sirtex Wilmington LLC [Sirtex Medical Pty Ltd] | Syringe Shield | 2003-12-19 |
Sirtex Singapore Manufacturing Pte Ltd [Sirtex Medical Pty Ltd] | Syringe Shield | 2003-12-19 |
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd] | Syringe Shield | 2003-12-19 |
Sirtex Wilmington LLC [Sirtex Medical Pty Ltd] | V-Vial | 2003-12-19 |
Sirtex Wilmington LLC [Sirtex Medical Pty Ltd] | SIR-Spheres V-Vial | 2003-12-19 |
Sirtex Wilmington LLC [Sirtex Medical Pty Ltd] | SIR-Spheres Delivery Set | 2003-12-19 |
Sirtex Wilmington LLC [Sirtex Medical Pty Ltd] | SIR-Spheres Accessories Pack | 2003-12-19 |
Sirtex Singapore Manufacturing Pte Ltd [Sirtex Medical Pty Ltd] | V-Vial | 2003-12-19 |
Sirtex Singapore Manufacturing Pte Ltd [Sirtex Medical Pty Ltd] | SIR-Spheres V-Vial | 2003-12-19 |
Sirtex Singapore Manufacturing Pte Ltd [Sirtex Medical Pty Ltd] | SIR-Spheres Delivery Set | 2003-12-19 |
Sirtex Singapore Manufacturing Pte Ltd [Sirtex Medical Pty Ltd] | SIR-Spheres Accessories Pack | 2003-12-19 |
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd] | V-Vial | 2003-12-19 |
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd] | SIR-Spheres V-Vial | 2003-12-19 |
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd] | SIR-Spheres Delivery Set | 2003-12-19 |
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd] | SIR-Spheres Accessories Pack | 2003-12-19 |
MaryLou Stroumbos [Sirtex Medical Pty Ltd] | V-Vial | 2003-12-19 |
MaryLou Stroumbos [Sirtex Medical Pty Ltd] | SIR-Spheres V-Vial | 2003-12-19 |
MaryLou Stroumbos [Sirtex Medical Pty Ltd] | SIR-Spheres Delivery Set | 2003-12-19 |
MaryLou Stroumbos [Sirtex Medical Pty Ltd] | SIR-Spheres Accessories Pack | 2003-12-19 |
| Sirtex Medical Pty Ltd | SIR-SPHERES | 2003-04-24 |
| Sirtex Medical Pty Ltd | SIR-SPHERES | 2002-03-05 |