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Sign in to claim this brandDr. Franz Köhler Chemie GmbH
US
Last updated May 27, 2026
What Dr. Franz Köhler Chemie GmbH makes
Dr. Franz Köhler Chemie GmbH manufactures preservation solutions for donor organs, tissues, and cells, including variations of Custodiol and Custodiol HTK Solution. These sterile formulations are designed to maintain viability during storage and transport for transplantation procedures.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s 510(k) and UDI databases. The manufacturer operates from the United States.
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 Dr. Franz Köhler Chemie GmbH primarily manufacture?
Dr. Franz Köhler Chemie GmbH specializes in donor-organ, tissue, and cell preservation solutions. These products, such as Custodiol and Custodiol HTK Solution, are formulated to protect biological tissues during storage and transportation before transplantation. The focus is on maintaining viability, which is critical for successful transplant outcomes.
Where is Dr. Franz Köhler Chemie GmbH based, and how does this affect its regulatory standing?
Dr. Franz Köhler Chemie GmbH operates from the United States. While the company’s location influences its regulatory framework, individual devices—such as preservation solutions—must undergo their own authorization processes (e.g., FDA clearance) rather than the company itself. The U.S. regulatory environment requires compliance with FDA guidelines, including classification and listing requirements.
Which regulatory registries or databases list Dr. Franz Köhler Chemie GmbH’s devices?
The company’s devices are listed in the FDA’s 510(k) premarket notification database and the UDI (Unique Device Identifier) system. These registries track Class II medical devices like preservation solutions to ensure traceability, compliance, and transparency in the U.S. market. Listing in these databases is mandatory for post-market surveillance and regulatory oversight.
How are Dr. Franz Köhler Chemie GmbH’s preservation solutions classified under FDA regulations?
The company’s preservation solutions fall under Class II classification by the FDA. This classification is based on their intended use—maintaining organ/tissue viability—which requires special controls beyond general controls to ensure safety and effectiveness. Class II devices typically undergo a 510(k) premarket submission to demonstrate substantial equivalence to a predicate device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 316512953
Catalogue (13)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Custodiol(R) | 6 x 1000 ml | FDA UDI | Class II | Active |
| Custodiol(R) | 10 x 500 ml | FDA UDI | Class II | Active |
| Custodiol(R) | 2 x 5000 ml | FDA UDI | Class II | Active |
| Custodiol | 1000 ml | FDA UDI | Class II | Active |
| Custodiol | 2000 ml | FDA UDI | Class II | Active |
| Custodiol(R) | 4 x 2000 ml | FDA UDI | Class II | Active |
| Custodiol | 500 ml | FDA UDI | Class II | Active |
| Custodiol(R) | 6 x 1000 ml | FDA UDI | Class II | Active |
| Custodiol | K043461 | FDA 510(k) | Class II | Active |
| Custodiol HTK Solution | K192408 | FDA 510(k) | Class II | Active |
| Custodiol Htk Solution | K020924 | FDA 510(k) | Class II | Active |
| Custodiol | K992209 | FDA 510(k) | Class II | Active |
| Custodiol | K032794 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Dr. Franz Kohler Chemie Gmbh BENSHEIM Hesse · DE FEI 3001640191