Denise M Oppermann

FDA Filings

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

FDA Registration(s)
Registration Number3007699073
FEI Number3007699073
NameDenise M Oppermann
Owner & OperatorXenios AG
Contact AddressIm Zukunftspark 1
Heilbronn DE-BW Baden-Wurttemberg 74076 DE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address920 Winter Street
Waltham, MA 02451 US
Establishment TypeManufacture Medical Device

Registration Number3010850471
FEI Number3010850471
NameDenise M Oppermann
Owner & OperatorVivonic GmbH
Contact AddressKurfuerst-Eppstein-Ring 4
Sailauf DE-BY Bayern 63877 DE
Official Correspondent
  • Andreas Hessberger
  • 049-6093-9713111-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address920 Winter Street
Waltham, MA 02451 US
Establishment TypeManufacture Medical Device

Registration Number3002845651
FEI Number3002845651
NameDenise M Oppermann
Owner & OperatorXenios AG
Contact AddressIm Zukunftspark 1
Heilbronn DE-BW Baden-Wurttemberg 74076 DE
US Agent
Importing Logistics Registration
ImporterXenios AG
Address2950 S. State Street, Suite 340
Ann Arbor, MI 48103 UNITED STATES
Email Addressleann.christman@xenios-ag.com
Phone1 734 2231503
Importer TypeAGENT
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address920 Winter Street
Waltham, MA 02451 US
Establishment Type
  • Export Device to the United States But Perform No Other Operation on Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device
Company
DeviceDate
Denise M Oppermann [Xenios AG]
Water Coupling 3/8" Hansen, Straight2019-02-25
Denise M Oppermann [Xenios AG]
Water Coupling 3/8" Hansen, 90 degrees2019-02-25
Denise M Oppermann [Xenios AG]
Water Coupling 1/2" Hansen, Straight2019-02-25
Denise M Oppermann [Xenios AG]
Water Coupling 1/2" Hansen, 90 degrees2019-02-25
Denise M Oppermann [Xenios AG]
Holder for hilite 7000 Oxygenator2019-02-25
Denise M Oppermann [Xenios AG]
Holder for Pediatric Oxygenator2019-02-25
Denise M Oppermann [Vivonic GmbH]
AquaC UNO H2015-11-05
Denise M Oppermann [Vivonic GmbH]
AquaBplus2014-06-10
Denise M Oppermann [Vivonic GmbH]
AquaBplus & AquaBplus HF2014-06-10
Denise M Oppermann [Vivonic GmbH]
AquaBplus & AquaBplus B22014-06-10
Denise M Oppermann [Vivonic GmbH]
AquaBplus & AquaBplus B2 & AquaBplus HF2014-06-10
Denise M Oppermann [Xenios AG]
Medos Hilite 1000 & 800 LT Infant Oxygenator2014-02-27
Denise M Oppermann [Xenios AG]
Medos Hilite 1000 & 800 LT Infant Oxygenator2014-02-27
Denise M Oppermann [Xenios AG]
Medos Hilite 2800 & 2400 LT Oxygenators2014-02-27
Denise M Oppermann [Xenios AG]
Medos Hilite 2800 & 2400 LT Oxygenators2014-02-27
Denise M Oppermann [Xenios AG]
Medos Hilite 2800 & 2400 LT Oxygenators2014-02-27
Denise M Oppermann [Xenios AG]
Medos Hilite 2800 & 2400 LT Oxygenators2014-02-27
Denise M Oppermann [Xenios AG]
Medos Hilite 7000 & 7000 LT Oxygenator2014-01-17
Denise M Oppermann [Xenios AG]
Medos Hilite 7000 & 7000 LT Oxygenator2014-01-17

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