DR. FRANZ KOHLER CHEMIE GMBH

FDA Device Registration & Listing · BENSHEIM Hesse, DE · Registration 9615922

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9615922
FEI Number
3001640191
Entity Name
DR. FRANZ KOHLER CHEMIE GMBH
City/State/Country
BENSHEIM Hesse, DE
Establishment Address
WERNER-VON-SIEMENS-STR. 14-28, BENSHEIM Hesse D-64625, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
DR. FRANZ KOHLER CHEMIE GMBH (Owner Number: 9034968)
Owner / Operator Contact Address
Werner-von-Siemens-Strasse 14-28, --, Bensheim, DE-HE D-64625, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K020924
PMA Number
N/A

All Registered Proprietary Names

Custodiol Custodiol Htk Solution

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KDL Set, Perfusion, Kidney, Disposable Gastroenterology, Urology Class 2 876.5880 2007-10-29
MSB System And Accessories, Isolated Heart, Transport And Preservation Gastroenterology, Urology Class 2 876.5880 2007-10-29
KDL Set, Perfusion, Kidney, Disposable Gastroenterology, Urology Class 2 876.5880 2007-10-29

Official Correspondent

Clifton Czarnojon

US Agent Details

John Ziobro Business: SpectraMedEx, LLC Email: jfz@spectramedex.com Phone: (262) 7198922

Related Public Records

Same Entity

DR. FRANZ KOHLER CHEMIE GMBH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615922. Last updated year: 2026. Please use registration number 9615922 when referencing this establishment in official correspondence.
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