Data / Medical devices / Germany / Sirtex Germany Manufacturing GmbH
Sirtex Germany Manufacturing GmbH: FDA-registered device maker in Frankfurt am Main Hesse, Germany, 1 PMA approval
Sirtex Germany Manufacturing GmbH is registered with the FDA (registration 3013070673) in Frankfurt am Main Hesse, Germany. It lists 5 device types. The FDA files 1 PMA approval under its listings, the newest dated March 5, 2002. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3013070673
- Address
- Industriepark Hoechst, Building G808, Frankfurt am Main Hesse, Germany, 65926
- Owner or operator
- Sirtex Medical Inc. (9047689)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- December 19, 2003
- Registered through
- 2026
- Brand names listed
- SIR-Spheres, SIR-Spheres Accessories Pack, SIR-Spheres Delivery Box, SIR-Spheres Delivery Set, SIR-Spheres Select, SIR-Spheres Select Y-90 resin microspheres, SIR-Spheres V-Vial, SIR-Spheres V-Vial Holder and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Holder, Syringe, Lead | IWR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Microspheres Radionuclide | NAW | 3 | Manufacturer | accessdata.fda.gov |
| Shield, Protective, Personnel | KPY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Shield, Vial | IWW | 1 | Repackager or relabeler | accessdata.fda.gov |
| System, Applicator, Radionuclide, Manual | IWJ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 5, 2002 | P990065 | SIR-SPHERES | NAW | 14 | May 7, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Shield, Vial
- All makers of System, Applicator, Radionuclide, Manual
- All makers of Shield, Protective, Personnel
- All makers of Microspheres Radionuclide
- All makers of Holder, Syringe, Lead
Updated May 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.