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Biocartis Nv, Mechelen, Belgium – FDA Inspections

Inspection records and compliance data for Biocartis Nv in Mechelen. 2 FDA inspections on record, last inspected July 03, 2025.

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Company Profile

This profile covers Biocartis Nv based in Mechelen, Belgium.

FDA Inspection History

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

First inspected December 1, 2017. Last inspected July 3, 2025.

FDA inspections (2)

DateResultFDA center(s)Insp. #
July 3, 2025NAIMedical Devices & Rad Health · Postmarket Assurance: Devices1277035
December 1, 2017Not classifiedMedical Devices & Rad Health1045812
FDA documents

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

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Company Information

Name

Biocartis Nv

FEI Number

3009972873

Address

B 3, Generaal De Wittelaan 11, Mechelen, Belgium

Country

Belgium

ID: 86275d3f-87f4-4444-99cd-2d07069cd584

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