Sirtex Singapore Manufacturing Pte L T D

FDA Filings

This page includes the latest FDA filings for Sirtex Singapore Manufacturing Pte L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
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

FDA Filings

Device
Company
DeviceDate
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 Singapore Manufacturing Pte Ltd [Sirtex Medical Pty Ltd]
SIR-Spheres Delivery Box2003-12-19
Sirtex Singapore Manufacturing Pte Ltd [Sirtex Medical Pty Ltd]
SIR-Spheres V-Vial Holder2003-12-19
Sirtex Singapore Manufacturing Pte Ltd [Sirtex Medical Pty Ltd]
Syringe Shield2003-12-19
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

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