Biocartis N V

FDA Filings

This page includes the latest FDA filings for Biocartis N V. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Biocartis N V holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• BIOCARTIS NV

FDA Registration(s)

• Registration Number: 3009972873
• FEI Number: 3009972873
• Name: BIOCARTIS NV
• Owner & Operator: Biocartis NV
• Contact Address: Generaal De Wittelaan 11 B3 ; Mechelen BE-VAN Antwerpen 2800 BE
• Official Correspondent:
  • Carole E Harris
  • 32-156-32600-x
• US Agent:
  • Carole E.N. Harris
  • Biocartis US Inc
  • 901 3319823
  • charris@biocartis.com
• Importing Logistics Registration:
  • Importer: Biocartis NV
  • Address: Generaal De Wittelaan 11 B3 ; Mechelen, 2800 BELGIUM
  • Subdivision: BE-VAN
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Generaal De Wittelaan 11 B ; Mechelen Antwerpen, 2800 BE
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 15415219000758 Biocartis NV	Idylla™ MSI Test	2023-05-11
GUDID 15415219000635 Biocartis NV	Idylla™ Respiratory (IFV-RSV) Panel A1030/6	2018-11-23
GUDID 05415219000126 Biocartis NV	Idylla™ System P1010	2018-03-29
GUDID 05415219000119 Biocartis NV	Idylla™ System P0010	2018-03-29
PMN K163628 | OCC BIOCARTIS NV	Idylla Respiratory (IFV-RSV) Panel	2017-09-06
OOI BIOCARTIS NV	Idylla? System (Idylla? Console and Idylla? Instrument)	2017-07-13