Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009088444

FEI Number

3009088444

Entity Name

Sirtex Singapore Manufacturing Pte Ltd

City/State/Country

Singapore Central Singapore, SG

Establishment Address

50 Science Park Road, #01-01, Science Park II, Singapore Central Singapore 117406, SG

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Sirtex Medical Inc. (Owner Number: 9047689)

Owner / Operator Contact Address

300 Unicorn Park Dr., 2nd Fl., Woburn, MA 01801, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SIROS D-Vial Prep Set SIR-Spheres V-Vial Holder SIR-Spheres Delivery Set SIR-Spheres Accessories Pack SIR-Spheres V-Vial SIROS Delivery Set V-Vial Syringe Shield SIR-Spheres SIR-Spheres Select Y-90 resin microspheres SIR-Spheres Select SIR-Spheres microspheres SIR-Spheres Delivery Box SIROS Delivery Dome

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IWW	Shield, Vial	Radiology	Class 1	892.6500	2003-12-19
IWJ	System, Applicator, Radionuclide, Manual	Radiology	Class 1	892.5650	2003-12-19
IWR	Holder, Syringe, Lead	Radiology	Class 1	892.6500	2003-12-19
NAW	Microspheres Radionuclide	Unknown	Class 3	N/A	2007-10-23
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2003-12-19

Official Correspondent

Jeffrey Cyr

US Agent Details

Jeffrey Cyr Business: Sirtex Medical Inc. Email: Jeffrey.Cyr@sirtex.com Phone: (781) 7213889

Related Public Records

Same Entity

Sirtex Medical Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013070673	Sirtex Germany Manufacturing GmbH	Frankfurt am Main Hesse, DE
3012690638	SIRTEX MEDICAL INC.	Woburn, MA, US
3005579300	Sirtex Wilmington LLC	Wilmington, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K973037	Avid N.I.T., Inc.	N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000	1998-01-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-2012	Worldwide Medical Technologies, LLC	1	Prostrate Seeding Applicator Needle. Product code PSS1820AT Packed in boxes of (25) with five Single Packs and four five packs or as singles or five packs. Worldwide Medical Technologies, LLC Used to introduce radionuclide seeds of 1-125 or Pd-103 into the body for radiation therapy. This device is typically used in the transperineal approach for placing radionuclide seeds in the prostate

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009088444. Last updated year: 2026. Please use registration number 3009088444 when referencing this establishment in official correspondence.