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Sign in to claim this brandBarkey GmbH & Co. KG
Germany·DE-MF-000005854
Last updated May 30, 2026
What Barkey GmbH & Co. KG makes
Barkey GmbH & Co. KG manufactures conduction-based blood and fluid warmers, including models like the Barkey S-line and the plasmatherm series. These devices are designed to maintain or raise the temperature of intravenous fluids and blood products during medical procedures. The company also produces the Barkey warming center III DTM, a system for controlled warming applications in clinical settings.
The company’s products are classified under EU Medical Device Regulation as Class II or Class IIa devices, reflecting their moderate risk level. These devices are registered in the EU’s EUDAMED database, the FDA’s 510(k) premarket notification system, and the FDA’s Unique Device Identifier (UDI) database. Barkey GmbH & Co. KG 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 Barkey GmbH & Co. KG manufacture?
Barkey GmbH & Co. KG specializes in conduction-based blood and fluid warmers. These devices are designed to maintain or increase the temperature of intravenous fluids and blood products during medical procedures, ensuring optimal patient outcomes. Examples include the Barkey S-line series and the plasmatherm line, as well as the Barkey warming center III DTM system for controlled warming applications.
Where is Barkey GmbH & Co. KG based?
Barkey GmbH & Co. KG is headquartered in Germany. The company’s location in Germany aligns with its focus on manufacturing and distributing medical devices that comply with European and international regulatory standards.
In which regulatory registries are Barkey GmbH & Co. KG’s devices listed?
Barkey GmbH & Co. KG’s devices are registered in multiple key regulatory databases, including the EU’s EUDAMED system for medical device tracking, the FDA’s 510(k) premarket notification database, and the FDA’s Unique Device Identifier (UDI) database. These registries ensure transparency and compliance with global medical device regulations.
How are Barkey GmbH & Co. KG’s devices classified under medical device regulations?
Barkey GmbH & Co. KG’s devices are classified under the EU Medical Device Regulation as either Class II or Class IIa. This classification reflects their moderate risk level, requiring compliance with specific safety and performance standards to ensure they meet regulatory requirements for use in clinical settings.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Germany
- Address
- 2, Im Leuschnerpark, Griesheim, Germany
- Website
- www.barkey.de
- —
- —
- [email protected]
- Phone
- +49 5202 9801 0
- PRRC Contact
- Ian Stuart Riley
- EUDAMED SRN
- DE-MF-000005854
- FDA FEI Number
- —
- DUNS Number
- 312555782
Catalogue (78)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| plasmatherm | 00000471 | EUDAMED | Class IIa | Active |
| Barkey S-line | 00011142 | EUDAMED | Class IIa | Active |
| Barkey S-line | 00011166 | EUDAMED | Class IIa | Active |
| plasmatherm | 00000494 | EUDAMED | Class IIa | Active |
| Barkey S-line | 00011146 | EUDAMED | Class IIa | Active |
| Barkey S-line | 00011141 | EUDAMED | Class IIa | Active |
| plasmatherm | 00003475 | EUDAMEDFDA UDI | Class IIa | Active |
| plasmatherm | 0000448 | EUDAMEDFDA UDI | Class IIa | Active |
| plasmatherm | 00010778 | EUDAMED | Class IIa | Active |
| Barkey warming center III DTM | 00011192 | EUDAMED | Class IIa | Active |
| plasmatherm | 00003289 | EUDAMED | Class IIa | Active |
| plasmatherm | 00000484 | EUDAMED | Class IIa | Active |
| warming center II | 00011177 | EUDAMED | Class IIa | Active |
| plasmatherm | 00010358 | EUDAMED | Class IIa | Active |
| plasmatherm | 00000507 | EUDAMED | Class IIa | Active |
| Barkey S-line | 00011167 | EUDAMED | Class IIa | Active |
| plasmatherm | 00010336 | EUDAMED | Class IIa | Active |
| Barkey S-line | 00011153 | EUDAMED | Class IIa | Active |
| Barkey S-line | 00011158 | EUDAMED | Class IIa | Active |
| plasmatherm | 00000491 | EUDAMED | Class IIa | Active |
| Barkey warming center III DTM | 00011196 | EUDAMED | Class IIa | Active |
| plasmatherm | 00010357 | EUDAMED | Class IIa | Active |
| Barkey S-line | 00011172 | EUDAMED | Class IIa | Active |
| plasmatherm | 00003287 | EUDAMED | Class IIa | Active |
| Barkey S-line | 00011157 | EUDAMED | Class IIa | Active |
| plasmatherm | 00003282 | EUDAMED | Class IIa | Active |
| plasmatherm | 0003293 | EUDAMED | Class IIa | Active |
| plasmatherm | 00000498 | EUDAMEDFDA UDI | Class IIa | Active |
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