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KLS Martin SE & Co. KG, Muhlheim An Der Donau, Germany – FDA Inspections

Inspection records and compliance data for KLS Martin SE & Co. KG in Muhlheim An Der Donau. 3 FDA inspections on record, last inspected April 09, 2025.

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Company Profile

This profile covers KLS Martin SE & Co. KG based in Muhlheim An Der Donau, Germany.

FDA Inspection History

FDA inspections
3
OAI
0
VAI
1
NAI
0
Unclassified
2
Form 483s
0
Warning letters
0

First inspected September 28, 2011. Last inspected April 9, 2025.

Most cited issue areas

  • Documentation1 inspection
  • Nonconforming product, Lack of or inadequate procedures1 inspection
  • Records of MDR Investigation1 inspection

FDA inspections (3)

DateResultFDA center(s)Insp. #
April 9, 2025Not classifiedMedical Devices & Rad Health1258115
August 23, 2018Not classifiedMedical Devices & Rad Health1067685
September 28, 2011VAIMedical Devices & Rad Health · Postmarket Assurance: Devices750308
FDA documents

No Form 483s, Warning Letters or EIRs on record.

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AGFA-GEVAERT HEALTHCARE GMBH
Stefan Rath, MD
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Company Information

Name

KLS Martin SE & Co. KG

FEI Number

3002807464

Address

Kolbinger Str. 10, Muhlheim An Der Donau, Germany

Country

Germany

ID: 3ea282e3-9eda-4389-940a-399a1c20e4c6

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