Data / Medical devices / Austria / Takeda Manufacturing Austria AG
Takeda Manufacturing Austria AG: FDA-registered device maker in VIENNA Wien, Austria, 2 510(k) clearances
Takeda Manufacturing Austria AG is registered with the FDA (registration 9616848) in VIENNA Wien, Austria. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 6, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616848
- FEI number
- 3002669612
- Address
- Industriestrasse 67, VIENNA Wien, Austria, A1220
- Owner or operator
- Takeda Pharmaceuticals U.S.A., Inc. (10049748)
- Roles
- Contract manufacturer, Exporter to the US
- First device listed
- August 9, 2016
- Registered through
- 2026
- Brand names listed
- Recombinant Factor VIII Substrate, Porcine Sequence
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Control, Plasma, Abnormal | GGC | 2 | Contract manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Exporter to the US | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Exporter to the US | accessdata.fda.gov |
| System/Device, Pharmacy Compounding | NEP | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 6, 2007 | K072894 | SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) | FPA | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| August 16, 2007 | K071459 | B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES | FMF | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System/Device, Pharmacy Compounding
- All makers of Control, Plasma, Abnormal
- All makers of Syringe, Piston
- All makers of Set, Administration, Intravascular
Updated November 6, 2007. 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.