Sirtex Germany Manufacturing GmbH

FDA Device Registration & Listing · Frankfurt am Main Hesse, DE · Registration 3013070673

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013070673
FEI Number
3013070673
Entity Name
Sirtex Germany Manufacturing GmbH
City/State/Country
Frankfurt am Main Hesse, DE
Establishment Address
Industriepark Hoechst, Building G808, Frankfurt am Main Hesse 65926, DE
Establishment Type(s)
Repack or Relabel Medical Device,Manufacture 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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SIR-Spheres SIR-Spheres Select Y-90 resin microspheres SIR-Spheres Select SIR-Spheres microspheres Syringe Shield SIR-Spheres Delivery Set SIR-Spheres Accessories Pack SIR-Spheres V-Vial SIROS Delivery Set V-Vial

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NAW Microspheres Radionuclide Unknown Class 3 N/A 2007-10-23
IWR Holder, Syringe, Lead Radiology Class 1 892.6500 2003-12-19
IWJ System, Applicator, Radionuclide, Manual Radiology Class 1 892.5650 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
3009088444 Sirtex Singapore Manufacturing Pte Ltd Singapore Central Singapore, SG
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

Similar Registrations

Registration Number Establishment Name Location
1450662 Isomedix Operations, Inc. Libertyville, IL, US
3009088444 Sirtex Singapore Manufacturing Pte Ltd Singapore Central Singapore, SG
3005579300 Sirtex Wilmington LLC Wilmington, MA, US
2134265 BOSTON SCIENTIFIC CORPORATION Maple Grove, MN, US
3029900933 LEMER PAX AMERICA Montreal Quebec, CA
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013070673. Last updated year: 2026. Please use registration number 3013070673 when referencing this establishment in official correspondence.
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