Greiner Bio-One GmbH
AT-MF-000024608 · Austria · Kremsmünster
Greiner Bio-One GmbH is registered in the European database on medical devices as a manufacturer, with 296 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 92 |
|---|
Most frequent device types declared: Greiner Bio-One Saliva Transfer Tube, SAFETY Blood Collection/Infusion Sets, VACUETTE® Blood Culture Holder, VACUETTE® TUBE 4NC ESR sodium citrate 3.2%, VACUETTE® TUBE CAT Serum Clot Activator.
Among these devices, 233 are declared sterile.
Devices declared under this manufacturer
- Greiner Bio-One Saliva Transfer Tube 3.5 ml 13x75 orange cap-orange ri
- SAFETY Blood Collection Set + Luer Adapter 23G x 3/4\
- SAFETY Blood Collection/Infusion Set 21G x 3/4\
- SAFETY Blood Collection/Infusion Set 23G x 3/4\
- VACUETTE® 3 ml Virus Stabilization Tube 13x100 red cap-white ring, PRE
- VACUETTE® Blood Culture Holder non-sterile
- VACUETTE® TUBE 1 ml CAT Serum Clot Activator 13x75 red cap-white ring,
- VACUETTE® TUBE 10 ml Urine CCM 16x100 yellow cap-black ring, G-barcode
- VACUETTE® TUBE 10 ml Z Urine No Additive 16x100 black cap-black ring,
- VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 gold ca
- VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 white c
- VACUETTE® TUBE 4 ml CAT Serum Clot Activator 13x75 red cap-black ring,
Showing 12 of 296 declared devices.
Catalogue references include 450082V1, 450092V1, 450181, 454098, 454228, 454260.
European nomenclature codes declared: W050101010201, W0501010203, W05010202, A01010201, A01010502, V010401.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | GREINER BIO-ONE GMBH (AT) · FDA 8020040 |
| Devices in EUDAMED | 296 |
| Country of registration | Austria |
Device-level evidence
| Devices with a numeric GTIN | 296 |
|---|---|
| Found in the U.S. device database | 115 |
| Share | 38.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | GREINER BIO ONE GMBH |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| First licensed | 2005-04-29 |
Licence types: Device Family (2), Device Group Family (2).
Licensed under: VACUETTE MULTI DRAWING NEEDLE, VACUETTE BLOOD COLLECTION SET, VACUETTE QUICKSHIELD COMPLETE, VACUETTE EVOPROTECT SAFETY BLOOD COLLECTION / .
North American profile: Both markets. Greiner Bio-One GmbH is registered in both the United States and Canada.