Data / Medical devices / Austria / Greiner Bio-One GMBH
Greiner Bio-One GMBH: FDA-registered device maker in Rainbach im Muehlkreis Oberosterreich, Austria, 3 510(k) clearances
Greiner Bio-One GMBH is registered with the FDA (registration 3007817041) in Rainbach im Muehlkreis Oberosterreich, Austria. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 19, 2018. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3007817041
- Address
- Gewerbepark 2, Rainbach im Muehlkreis Oberosterreich, Austria, 4261
- Owner or operator
- GREINER BIO-ONE NA (8020040)
- Roles
- Manufacturer
- First device listed
- January 13, 1998
- Registered through
- 2026
- Brand names listed
- VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set, VACUETTE QUICKSHIELD Safety Tube Holder, Vacuette Quickshield Complete PLUS Safety Tube Holder, Vacuette Quickshield Complete Safety Tube Holder
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 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 |
|---|---|---|---|---|---|---|
| April 19, 2018 | K173757 | VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set | FMI | Substantially Equivalent | Greiner Bio-One Na, Inc. | accessdata.fda.gov |
| September 14, 2007 | K072320 | GREINER VACUETTE QUICKSHIELD COMPLETE | FMI | Substantially Equivalent | Greiner Bio-One North America, Inc. | accessdata.fda.gov |
| December 29, 2003 | K033478 | VACUETTE QUICKSHIELD SAFETY TUBE HOLDER | FMI | Substantially Equivalent | Greiner Bio-One Vacuette North America | accessdata.fda.gov |
Compare with other makers
Updated April 19, 2018. 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.