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Data / Medical devices / Austria / Greiner Bio-One GMBH

Greiner Bio-One GMBH: FDA-registered device maker in KREMSMUENSTER Oberosterreich, Austria, 34 510(k) clearances

Greiner Bio-One GMBH is registered with the FDA (registration 8020040) in KREMSMUENSTER Oberosterreich, Austria. It lists 16 device types. The FDA files 34 510(k) clearances under its listings, the newest dated July 8, 2022. 1 recall event names it as the recalling firm. 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.

Get makers like this oneWatch Greiner Bio-One GMBH
FDA registration number
8020040
FEI number
3000974732
Address
Bad Haller Strasse 32, KREMSMUENSTER Oberosterreich, Austria, A-4550
Owner or operator
GREINER BIO-ONE NA (8020040)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
First device listed
June 23, 1997
Registered through
2026
Brand names listed
Blood Transfer Unit, HOLDEX Single-Use Holder PP, single-packed, MiniCollect Bllod Collection Tube Lithium Heparin Sep, MiniCollect Blood Collection Tube K2EDTA, MiniCollect Blood Collection Tube Lithium Heparin, MiniCollect Blood Collection Tubes K3EDTA, MiniCollect Blood Collection Tubes Z Serum, MiniCollect Blood Collection Tubes Z Serum Sep and more

Devices it lists

DeviceProduct codeClassRoleSource
Blood/Plasma Collection Device For Dna TestingPJE2Manufacturer, Specification developeraccessdata.fda.gov
Cannula, InjectionFGY1Manufactureraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Container, Specimen, SterileFMH1Manufacturer, Specification developeraccessdata.fda.gov
Culture Media, Non-Propagating TransportJSM1Manufacturer, Specification developeraccessdata.fda.gov
Culture Media, Non-Selective And Non-DifferentialJSG1Contract manufacturer, Manufactureraccessdata.fda.gov
Device, Specimen CollectionLIO1Manufacturer, Specification developeraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Manufacturer, Specification developeraccessdata.fda.gov
Set, Administration, IntravascularFPA2Repackager or relabeler, Specification developeraccessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureFMK2Exporter to the USaccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Specification developeraccessdata.fda.gov
Transport Medium, Notified Per The Vtm GuidanceQMC1Contract manufacturer, Manufactureraccessdata.fda.gov
Tube, Collection, Capillary BloodGIO1Specification developeraccessdata.fda.gov
Tubes, Vacuum Sample, With AnticoagulantGIM2Manufacturer, Specification developeraccessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA2Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Urine Collection Kit (Excludes Hiv Testing)OIE1Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 8, 2022K220643DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety LancetsFMKSubstantially EquivalentHtl-Strefa S.Aaccessdata.fda.gov
January 25, 2019K182078MiniCollect K2E K2EDTA TubesJKASubstantially EquivalentGreiner Bio-One Na, Inc.accessdata.fda.gov
May 21, 2018K180545VACUETTE SAFELINK Holder with male luer lockFMISubstantially EquivalentGreiner Bio-One Na, Inc.accessdata.fda.gov
April 19, 2018K173757VACUETTE EVOPROTECT Safety Blood Collection / Infusion SetFMISubstantially EquivalentGreiner Bio-One Na, Inc.accessdata.fda.gov
May 19, 2017K163073Sol-Care Safety Blood Collection Needle with and without Pre-Attached HolderJKASubstantially EquivalentSol-Millennium Medical, Inc.accessdata.fda.gov
March 6, 2017K163436Greiner Vacuette Urine Count and Culture, Mannitol tubeJSMSubstantially EquivalentGreiner Bio-One Na, Inc.accessdata.fda.gov
November 3, 2016K160532Greiner HoldexFMISubstantially EquivalentGreiner Bio-One Na, Inc.accessdata.fda.gov
January 10, 2013K122687BLOOD CULTURE HOLDERJKASubstantially EquivalentGreiner Bio-One North America, Inc.accessdata.fda.gov
July 25, 2012K121908SAFETY INFUSION SETFMISubstantially EquivalentGreiner Bio-One North America, Inc.accessdata.fda.gov
April 24, 2008K080235SAFETY INFUSION SETFMISubstantially EquivalentGreiner Bio-One Vacuette North Americaaccessdata.fda.gov
September 14, 2007K072320GREINER VACUETTE QUICKSHIELD COMPLETEFMISubstantially EquivalentGreiner Bio-One North America, Inc.accessdata.fda.gov
July 10, 2007K063357MINICOLLECT CAPILLARY BLOOD COLLECTION TUBESJKASubstantially EquivalentGreiner Bio-One North America, Inc.accessdata.fda.gov
August 14, 2006K061483VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLESFMISubstantially EquivalentGreiner Bio-One North America, Inc.accessdata.fda.gov
April 15, 2005K042927VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBESPJESubstantially EquivalentGreiner Bio-One Vacuette North Americaaccessdata.fda.gov
December 29, 2003K033478VACUETTE QUICKSHIELD SAFETY TUBE HOLDERFMISubstantially EquivalentGreiner Bio-One Vacuette North Americaaccessdata.fda.gov
January 27, 2003K023971VACUETTE TRACE ELEMENTS TUBESJKASubstantially EquivalentGreiner Bio-One Vacuette North Americaaccessdata.fda.gov
February 1, 2002K014104VACUETTE EDTA K2 TUBESPJESubstantially EquivalentGreiner Vacuette North America, Inc.accessdata.fda.gov
September 24, 2001K012043VACUETTE EDTA K2 GEL TUBESPJESubstantially EquivalentGreiner Vacuette North America, Inc.accessdata.fda.gov
July 12, 2001K011786VACUETTE SAFETY BLOOD COLLECTION SETFMISubstantially EquivalentGreiner Vacuette North America, Inc.accessdata.fda.gov
June 28, 2001K011699VACUETTE EVACUATED BLOOD COLLECTION TUBESJKASubstantially EquivalentGreiner Bio-One Vacuette North Americaaccessdata.fda.gov
June 25, 1999K991843GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBEJKASubstantially EquivalentGreiner Meditech, Inc.accessdata.fda.gov
December 28, 1998K983952GREINER VACUETTE BLOOD COLLECTION TUBEJKASubstantially EquivalentGreiner Meditech, Inc.accessdata.fda.gov
October 21, 1998K982998GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBEJKASubstantially EquivalentGreiner Meditech, Inc.accessdata.fda.gov
October 16, 1998K982999GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBEJKASubstantially EquivalentGreiner Meditech, Inc.accessdata.fda.gov
July 15, 1998K981619VACUETTE MULTIPLE SAMPLE LUER ADAPTERFMISubstantially EquivalentGreiner Meditech, Inc.accessdata.fda.gov
April 9, 1998K980768VACUETTE HOLDEXFMISubstantially EquivalentGreiner Meditech, Inc.accessdata.fda.gov
February 5, 1998K974873VACUETTE (MULTI-USE HOLDER)JKASubstantially EquivalentGreiner Meditech, Inc.accessdata.fda.gov
December 17, 1997K973620VACUETTE MULTI-SAMPLE NEEDLEFMISubstantially EquivalentGreiner Meditech, Inc.accessdata.fda.gov
May 12, 1997K971239GREINER VACUETTE BLOOD COLLECTION TUBEJKASubstantially EquivalentGreiner America, Inc.accessdata.fda.gov
May 12, 1997K971236GREINER VACUETTE BLOOD COLLECTION TUBEJKASubstantially EquivalentGreiner America, Inc.accessdata.fda.gov
May 2, 1997K971221GREINER VACUETTE BLOOD COLLECTION TUBEGIMSubstantially EquivalentGreiner America, Inc.accessdata.fda.gov
September 5, 1996K960860GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3JKASubstantially EquivalentGreiner America, Inc.accessdata.fda.gov
August 30, 1996K960858GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATORJKASubstantially EquivalentGreiner America, Inc.accessdata.fda.gov
August 30, 1996K960857GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATORJKASubstantially EquivalentGreiner America, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
November 19, 202495748Class IIOngoingVACUETTE SAFELINK, REF: 450210The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.accessdata.fda.gov

Compare with other makers

Updated January 3, 2025. 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.