Sirtex Medical Pty L T D

FDA Filings

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.

AUSTRALIAAUSTRALIAN STOCK EXCHANGESRXDUNS 755092467

Sirtex Medical Pty L T D holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number9710358
FEI Number3003428886
NameMaryLou Stroumbos
Owner & OperatorSirtex Medical Pty Ltd
Contact AddressShop 6 207 Pacific Highway
St Leonards AU-NSW New South Wales 2065 AU
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address300 Unicorn Park Drive
Woburn, MA 01801 US
Establishment TypeRepack or Relabel Medical Device



Registration Number3013070673
FEI Number3013070673
NameSirtex Germany Manufacturing GmbH
Owner & OperatorSirtex Medical Pty Ltd
Contact AddressShop 6 207 Pacific Highway
St Leonards AU-NSW New South Wales 2065 AU
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressIndustriepark Hoechst, Building G808
Frankfurt am Main, 65926 DE
Establishment Type
  • Repack or Relabel Medical Device
  • Manufacture Medical Device



Registration Number3009088444
FEI Number3009088444
NameSirtex Singapore Manufacturing Pte Ltd
Owner & OperatorSirtex Medical Pty Ltd
Contact AddressShop 6 207 Pacific Highway
St Leonards AU-NSW New South Wales 2065 AU
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address50 Science Park Road, #01-01 Science Park II
Singapore Not Applicable, 117406 SG
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device



Registration Number3005579300
FEI Number3005579300
NameSirtex Wilmington LLC
Owner & OperatorSirtex Medical Pty Ltd
Contact AddressShop 6 207 Pacific Highway
St Leonards AU-NSW New South Wales 2065 AU
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address16 Upton Drive Unit 2-4
Wilmington, MA 01887 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device



FDA Filings

Device
Company
DeviceDate
SIRTEX MEDICAL PTY LTD
SIR-Spheres Y-90 resin microspheres 2024-07-23
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-103002021-01-13
SIRTEX MEDICAL PTY LTD
SIROS D-Vial Prep Set SIR-102002021-01-13
SIRTEX MEDICAL PTY LTD
SIROS Delivery Dome SIR-101002021-01-13
SIRTEX MEDICAL PTY LTD
SIR-Spheres microspheres SIR-Y0012021-01-12
Sirtex Medical Pty Ltd
SIR-Spheres microspheres2017-03-24
Sirtex Medical Pty Ltd
SIR-SPHERES MICROSPHERES2017-01-18
Sirtex Medical Pty Ltd
SIR-SPHERES MICROSPHERES2015-02-27
Sirtex Medical Pty Ltd
SIR-SPHERE MICROSPHERES2014-10-09
Sirtex Medical Pty Ltd
SIR-SPHERES2012-07-17
Sirtex Medical Pty Ltd
SIR-SPHERES2008-01-18
Sirtex Wilmington LLC [Sirtex Medical Pty Ltd]
SIR-Spheres2007-10-23
Sirtex Wilmington LLC [Sirtex Medical Pty Ltd]
SIR-Spheres microspheres2007-10-23
Sirtex Singapore Manufacturing Pte Ltd [Sirtex Medical Pty Ltd]
SIR-Spheres2007-10-23
Sirtex Singapore Manufacturing Pte Ltd [Sirtex Medical Pty Ltd]
SIR-Spheres microspheres2007-10-23
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd]
SIR-Spheres2007-10-23
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd]
SIR-Spheres microspheres2007-10-23
Sirtex Wilmington LLC [Sirtex Medical Pty Ltd]
SIR-Spheres Delivery Box2003-12-19
Sirtex Singapore Manufacturing Pte Ltd [Sirtex Medical Pty Ltd]
SIR-Spheres Delivery Box2003-12-19
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd]
SIR-Spheres Delivery Box2003-12-19
Sirtex Wilmington LLC [Sirtex Medical Pty Ltd]
SIR-Spheres V-Vial Holder2003-12-19
Sirtex Singapore Manufacturing Pte Ltd [Sirtex Medical Pty Ltd]
SIR-Spheres V-Vial Holder2003-12-19
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd]
SIR-Spheres V-Vial Holder2003-12-19
Sirtex Wilmington LLC [Sirtex Medical Pty Ltd]
Syringe Shield2003-12-19
Sirtex Singapore Manufacturing Pte Ltd [Sirtex Medical Pty Ltd]
Syringe Shield2003-12-19
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd]
Syringe Shield2003-12-19
Sirtex Wilmington LLC [Sirtex Medical Pty Ltd]
V-Vial2003-12-19
Sirtex Wilmington LLC [Sirtex Medical Pty Ltd]
SIR-Spheres V-Vial2003-12-19
Sirtex Wilmington LLC [Sirtex Medical Pty Ltd]
SIR-Spheres Delivery Set2003-12-19
Sirtex Wilmington LLC [Sirtex Medical Pty Ltd]
SIR-Spheres Accessories Pack2003-12-19
Sirtex Singapore Manufacturing Pte Ltd [Sirtex Medical Pty Ltd]
V-Vial2003-12-19
Sirtex Singapore Manufacturing Pte Ltd [Sirtex Medical Pty Ltd]
SIR-Spheres V-Vial2003-12-19
Sirtex Singapore Manufacturing Pte Ltd [Sirtex Medical Pty Ltd]
SIR-Spheres Delivery Set2003-12-19
Sirtex Singapore Manufacturing Pte Ltd [Sirtex Medical Pty Ltd]
SIR-Spheres Accessories Pack2003-12-19
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd]
V-Vial2003-12-19
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd]
SIR-Spheres V-Vial2003-12-19
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd]
SIR-Spheres Delivery Set2003-12-19
Sirtex Germany Manufacturing GmbH [Sirtex Medical Pty Ltd]
SIR-Spheres Accessories Pack2003-12-19
MaryLou Stroumbos [Sirtex Medical Pty Ltd]
V-Vial2003-12-19
MaryLou Stroumbos [Sirtex Medical Pty Ltd]
SIR-Spheres V-Vial2003-12-19
MaryLou Stroumbos [Sirtex Medical Pty Ltd]
SIR-Spheres Delivery Set2003-12-19
MaryLou Stroumbos [Sirtex Medical Pty Ltd]
SIR-Spheres Accessories Pack2003-12-19
Sirtex Medical Pty Ltd
SIR-SPHERES2003-04-24
Sirtex Medical Pty Ltd
SIR-SPHERES2002-03-05

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