Xenios Ag

FDA Filings

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

Xenios Ag holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

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 Number3012942265
FEI Number3012942265
NameMedos Medizintechnik AG
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 AddressIm Zukunftspark 1
Heilbronn Baden-Wurttemberg, 74076 DE
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility

Registration Number3012172416
FEI Number3012172416
NameXenios AG
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 AddressIm Zukunftspark 1
Heilbronn Baden-Wurttemberg, 74076 DE
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
XENIOS AG
 Novalung System 300001622020-12-25
XENIOS AG
 Novalung System 320000042020-12-25
Xenios AG
XLung kit2020-03-10
Xenios AG
Trolley N2020-03-10
Xenios AG
Support for backup pump drive2020-03-10
Xenios AG
Novalung sensor box2020-03-10
Xenios AG
Novalung pump drive DP32020-03-10
Xenios AG
Novalung power supply2020-03-10
Xenios AG
Novalung control panel2020-03-10
Xenios AG
Novalung console2020-03-10
Xenios AG
Novalung battery pack2020-03-10
Xenios AG
Novalung System2020-03-10
Xenios AG
Infusion Stand compact2020-03-10
Xenios AG
IPS Pressure Sensor connecting cable2020-03-10
Xenios AG
Flow Sensor 3/8?x3/32?2020-03-10
Xenios AG
Compact holder2020-03-10
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
Medos Medizintechnik AG [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 1000 & 800 LT Infant Oxygenator2014-02-27
Medos Medizintechnik AG [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
Medos Medizintechnik AG [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
Medos Medizintechnik AG [Xenios AG]
Medos Hilite 7000 & 7000 LT Oxygenator2014-01-17
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

Related Finance Registrations
NCAGE CodeCM701XENIOS AG
CAGE CodeCM701XENIOS AG
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