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MiE medical imaging electronics GmbH, Seth, Germany – FDA Inspections

Inspection records and compliance data for MiE medical imaging electronics GmbH in Seth. 2 FDA inspections on record, 2 Form 483s, last inspected October 12, 2023.

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Company Profile

This profile covers MiE medical imaging electronics GmbH based in Seth, Germany.

FDA Inspection History

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

First inspected May 31, 2018. Last inspected October 12, 2023.

Most cited issue areas

  • Documented evaluation2 inspections
  • Complaints1 inspection
  • Design validation - documentation1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
October 12, 2023Not classifiedMedical Devices & Rad Health1220602
May 31, 2018Not classifiedMedical Devices & Rad Health · Radiation Control and Health Safety Act1053692
FDA documents

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

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Company Information

Name

MiE medical imaging electronics GmbH

FEI Number

3005128583

Address

Haupt Strasse 112, Seth, Germany

Country

Germany

ID: 3e8eb09e-5552-426a-9224-1e8aad48e252

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