Epigenomics Ag

FDA Filings

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

GERMANYXETRAECXDUNS 340886410
FDA Registration(s)
Registration Number3005968611
FEI Number3005968611
NameEPIGENOMICS AG
Owner & OperatorEpigenomics AG
Contact AddressGeneststrasse 5
Berlin DE-BE Berlin 10829 DE
Official Correspondent
  • Melanie Martini
  • 49-30-24345-349
US Agent
Importing Logistics Registration
ImporterMolecular Pathology Laboratory Network, Inc
Address250 East Broadway
Maryville, TN 37804 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressGeneststrasse 5
Berlin Berlin, 10829 DE
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device



Registration Number3015050487
FEI Number3015050487
NameEPIGENOMICS, INC.
Owner & OperatorEpigenomics AG
Contact AddressGeneststrasse 5
Berlin DE-BE Berlin 10829 DE
Official Correspondent
  • Melanie Martini
  • 49-30-24345-349
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address11055 Flintkote Avenue, Suite A
San Diego, CA 92121 US



FDA Filings

Device
Company
DeviceDate
EPIGENOMICS AG
Epi proColon2021-09-20
Epigenomics AG
Epi proColon M5-02-0012019-12-11
Epigenomics AG
Epi proColon M5-02-0032019-12-11
Epigenomics AG
Epi proColon M5-02-0022019-12-11
EPIGENOMICS AG
Epi proColon2019-08-30
EPIGENOMICS AG
Epi proColon2018-03-20
EPIGENOMICS AG
Epi proColon2016-11-18
EPIGENOMICS AG
Epi proColon2016-10-18
EPIGENOMICS AG
Epi proColon2016-04-25
EPIGENOMICS AG
Epi proColon2016-04-12

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