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Sign in to claim this brandGreiner Bio-One GmbH
Germany·DE-MF-000032396
Last updated September 18, 2026
About
A global partner for biotechnology, medical devices, in vitro diagnostics and research ✓ All about Greiner Bio-One as a company ✓ Online at www.gbo.com!
From the manufacturer's own website. Source
What Greiner Bio-One GmbH makes
Greiner Bio-One GmbH manufactures intravenous administration sets designed for invasive procedures, as well as evacuated blood collection tubes for in vitro diagnostics (IVD) with various additives, including K3EDTA, K2EDTA, clot activators, lithium heparin, and gel separators. The company also produces evacuated urine specimen containers, both without additives and with preservatives, for clinical sample collection.
These devices are classified under EU regulations as Class A, Class I, Class II, and IVD General, with listings in the EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. The manufacturer is based in Germany.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Greiner Bio-One GmbH manufacture?
Greiner Bio-One GmbH produces a range of medical devices primarily focused on sample collection and administration. Their most common products include invasive intravenous administration sets for medical procedures, as well as evacuated blood collection tubes used in in vitro diagnostics (IVD). These tubes come in various formulations, such as K3EDTA, K2EDTA, clot activators, lithium heparin with gel separators, and additive-free versions. Additionally, they manufacture evacuated urine specimen containers, both without additives and with preservatives, designed for clinical sample collection.
Where is Greiner Bio-One GmbH based, and how does that affect its regulatory compliance?
Greiner Bio-One GmbH is headquartered in Germany, which places its devices under the regulatory oversight of the European Union’s Medical Device Regulations (MDR) and In Vitro Diagnostic Regulation (IVDR). As a German manufacturer, its products are listed in the EUDAMED database, the official EU registry for medical devices. This ensures transparency and traceability for regulatory authorities and healthcare providers across the EU market.
Which regulatory registries list Greiner Bio-One’s devices, and why is this important?
Greiner Bio-One’s devices are listed in EUDAMED, the European Union’s centralised database for medical devices, and the FDA’s Unique Device Identifier (UDI) system in the United States. Inclusion in these registries is critical because it provides official documentation of device authorisation, facilitates traceability for regulatory inspections, and ensures healthcare professionals and patients can verify the legitimacy and compliance status of the products in use.
How are Greiner Bio-One’s devices classified under EU and US regulations?
Under EU regulations, Greiner Bio-One’s devices fall into multiple classification categories: Class A (low-risk devices like some urine containers), Class I (non-invasive devices like basic administration sets), Class II (devices with moderate risk, such as certain blood collection tubes), and IVD General (in vitro diagnostics like additive-free or additive-containing blood tubes). Classification determines the regulatory scrutiny and conformity assessment requirements each device must meet before being placed on the market.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Germany
- Address
- 2, Maybachstraße, Frickenhausen, Germany
- Website
- www.gbo.com
- facebook.com/GreinerBioOneDE
- [email protected]
- Phone
- +49 162 698 8 612
- PRRC Contact
- Anna Burk
- EUDAMED SRN
- DE-MF-000032396
- FDA FEI Number
- —
- DUNS Number
- 303639066
Catalogue (528)
Page 3 of 11| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MiniCollect | 450532 | FDA UDI | Class II | Active |
| Vacuette | 450061 | FDA UDI | Class II | Active |
| Vacuette | 454033 | FDA UDI | Class II | Active |
| Vacuette | 454297 | FDA UDI | Class II | Active |
| Vacuette | 454081 | FDA UDI | Class II | Active |
| Cellmaster | 680648-009 | FDA UDI | Class I | Unknown |
| Cellmaster | 680648 | FDA UDI | Class I | Unknown |
| MiniCollect | 450547 | FDA UDI | Class II | Active |
| Vacuette | 450122 | FDA UDI | Class II | Active |
| Cellstar | 661175 | FDA UDI | Class I | Unknown |
| Vacuette | 454334 | FDA UDI | Class II | Active |
| Vacuette | 456275 | FDA UDI | Class II | Active |
| Vacuette | 450121 | FDA UDI | Class II | Active |
| Vacuette | 450083 | FDA UDI | Class II | Active |
| Vacuette | 455043P | FDA UDI | Class II | Active |
| Vacuette | 455099P | FDA UDI | Class II | Active |
| Vacuette | 836075 | FDA UDI | Class I | Unknown |
| Vacuette | 454067PH | FDA UDI | Class II | Unknown |
| Cellstar | 660190-TRI | FDA UDI | Class I | Unknown |
| Vacuette | 454204H | FDA UDI | Class II | Unknown |
| Vacuette | 455243 | FDA UDI | Class I | Active |
| Celldisc | 678124 | FDA UDI | Class I | Unknown |
| Vacuette | 450239V1 | FDA UDI | Class II | Active |
| Vacuette | 455322 | FDA UDI | Class II | Unknown |
| Cellmaster | 680668 | FDA UDI | Class I | Unknown |
| Vacuette | 454217H | FDA UDI | Class II | Unknown |
| Cellstar | 658190-TRI | FDA UDI | Class I | Unknown |
| Cryo.s | 124263-128 | FDA UDI | Class I | Unknown |
| Vacuette | 454209CA | FDA UDI | Class II | Active |
| MiniCollect | 450521 | FDA UDI | Class II | Unknown |
| Vacuette | 456085 | FDA UDI | Class II | Active |
| Vacuette | 450181 | FDA UDI | Class II | Active |
| Vacuette | 450042 | FDA UDI | Class II | Unknown |
| Vacuette | 454209H | FDA UDI | Class II | Unknown |
| MiniCollect | 450420 | FDA UDI | Class I | Active |
| Vacuette | 454021H | FDA UDI | Class II | Unknown |
| Cellstar | 658195 | FDA UDI | Class I | Unknown |
| Vacuette | 450041 | FDA UDI | Class II | Active |
| MiniCollect | 450522 | FDA UDI | Class II | Unknown |
| Vacuette | 454351 | FDA UDI | Class II | Active |
| MiniCollect | 450436 | FDA UDI | Class I | Unknown |
| Vacuette | 455382 | FDA UDI | Class II | Unknown |
| Vacuette | 459010 | FDA UDI | Class I | Active |
| Vacuette | 450082 | FDA UDI | Class II | Active |
| Vacuette | 455092 | FDA UDI | Class II | Active |
| Vacuette | 455036 | FDA UDI | Class II | Active |
| Vacuette | 453031 | FDA UDI | Class I | Active |
| Vacuette | 459001 | FDA UDI | Class I | Active |
| MiniCollect | 450475 | FDA UDI | Class II | Unknown |
| Vacuette | 454247P | FDA UDI | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Greiner Bio-One Gmbh KREMSMUENSTER Oberosterreich · AT FEI 3000974732