Data / Medical devices / Austria / Biegler GMBH
Biegler GMBH: FDA-registered device maker in MAUERBACH Niederosterreich, Austria, 1 510(k) clearance
Biegler GMBH is registered with the FDA (registration 3005813632) in MAUERBACH Niederosterreich, Austria. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 12, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005813632
- Address
- Allhangstrasse 18a, MAUERBACH Niederosterreich, Austria, 3001
- Owner or operator
- BIEGLER GMBH (9069662)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 13, 2012
- Registered through
- 2026
- Brand names listed
- BW 685, BW 685S, Duplocath, EasySpray, Fibrinotherm, autopress
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Block, Heating | JRG | 1 | Contract manufacturer | accessdata.fda.gov |
| Infusor, Pressure, For I.V. Bags | KZD | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Contract manufacturer | accessdata.fda.gov |
| Warmer, Thermal, Infusion Fluid | LGZ | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| July 12, 2012 | K121198 | BW685, BW685S | LGZ | Substantially Equivalent | Biegler GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Block, Heating
- All makers of Warmer, Thermal, Infusion Fluid
- All makers of Infusor, Pressure, For I.V. Bags
- All makers of Syringe, Piston
Updated July 12, 2012. 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.