Ionisos

FDA Filings

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

FDA Registration(s)
Registration Number3010178296
FEI Number3003110073
NameIONISOS
Owner & OperatorIONISOS
Contact Address13 - Pontet Industrial Zone
CIVRIEUX-D'AZERGUES FR-NOTA 69380 FR
Official Correspondent
  • Christoph Herkens
  • 033-4-78064114-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressParc Dombes Cotiere Activites
Dagneux Ain, 01120 FR
Establishment Type
  • Sterilize Medical Device for Another Party (Contract Sterilizer)
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number3010325717
FEI Number3010325717
NameSTERYLENE
Owner & OperatorIONISOS
Contact Address13 - Pontet Industrial Zone
CIVRIEUX-D'AZERGUES FR-NOTA 69380 FR
Official Correspondent
  • Christoph Herkens
  • 033-4-78064114-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressZI Les Montoires 3 rue Gustave Eiffel
Gien Centre, 45500 FR
Establishment TypeSterilize Medical Device for Another Party (Contract Sterilizer)

Registration Number3003775072
FEI Number3003775072
NameMichael van der Woude
Owner & OperatorIONISOS
Contact Address13 - Pontet Industrial Zone
CIVRIEUX-D'AZERGUES FR-NOTA 69380 FR
Official Correspondent
  • Christoph Herkens
  • 033-4-78064114-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2500 Bee Cave Road Bldg 1, Suite 300
Austin, TX 78746 US
Establishment TypeSterilize Medical Device for Another Party (Contract Sterilizer)

Registration Number3002807295
FEI Number3002807295
NameMichael van der Woude
Owner & OperatorIONISOS
Contact Address13 - Pontet Industrial Zone
CIVRIEUX-D'AZERGUES FR-NOTA 69380 FR
Official Correspondent
  • Christoph Herkens
  • 033-4-78064114-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2500 Bee Cave Road Bldg 1, Suite 300
Austin, TX 78746 US
Establishment TypeSterilize Medical Device for Another Party (Contract Sterilizer)

Registration Number3011659185
FEI Number3011659185
NameSTERYLENE
Owner & OperatorIONISOS
Contact Address13 - Pontet Industrial Zone
CIVRIEUX-D'AZERGUES FR-NOTA 69380 FR
Official Correspondent
  • Christoph Herkens
  • 033-4-78064114-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address13 Zone Industrielle du Pontet
CIVRIEUX D AZERGUES Rhone, 69380 FR
Establishment TypeSterilize Medical Device for Another Party (Contract Sterilizer)

Registration Number3010329663
FEI Number3010329663
NameMichael van der Woude
Owner & OperatorIONISOS
Contact Address13 - Pontet Industrial Zone
CIVRIEUX-D'AZERGUES FR-NOTA 69380 FR
Official Correspondent
  • Christoph Herkens
  • 033-4-78064114-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2500 Bee Cave Road Building 1, Suite 300
Austin, TX 78746 US
Establishment TypeSterilize Medical Device for Another Party (Contract Sterilizer)

Registration Number3003617485
FEI Number3003617485
NameMichael van de Woude
Owner & OperatorIONISOS
Contact Address13 - Pontet Industrial Zone
CIVRIEUX-D'AZERGUES FR-NOTA 69380 FR
Official Correspondent
  • Christoph Herkens
  • 033-4-78064114-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2500 Bee Cave Road Bldg 1, Suite 300
Austin, TX 78746 US
Establishment TypeSterilize Medical Device for Another Party (Contract Sterilizer)

Registration Number3010191069
FEI Number3010191069
NameMichael van der Woude
Owner & OperatorIONISOS
Contact Address13 - Pontet Industrial Zone
CIVRIEUX-D'AZERGUES FR-NOTA 69380 FR
Official Correspondent
  • Christoph Herkens
  • 033-4-78064114-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2500 Bee Cave Road Bldg 1, Suite 300
Austin, TX 78746 US
Establishment TypeSterilize Medical Device for Another Party (Contract Sterilizer)

FDA Filings

Device
Company
DeviceDate
Michael van de Woude [IONISOS]
Icare tonometer probes, TP01s2019-12-05
Michael van de Woude [IONISOS]
Icare tonometer probes, TP01s2019-12-05
Michael van der Woude [IONISOS]
SpineJack? Expansion Kit 5.8mm2018-09-13
Michael van der Woude [IONISOS]
SpineJack? Expansion Kit 5.0mm2018-09-13
Michael van der Woude [IONISOS]
SpineJack? Expansion Kit 4.2mm2018-09-13
Michael van der Woude [IONISOS]
Injector Transfer Tube 5.0-5.8mm2018-09-13
Michael van der Woude [IONISOS]
Injector Transfer Tube 4.2mm2018-09-13
Michael van der Woude [IONISOS]
Cement Pusher 5.0-5.8mm2018-09-13
Michael van der Woude [IONISOS]
Cement Pusher 4.2mm2018-09-13
Michael van der Woude [IONISOS]
SpineJack? Preparation Kit 5.8mm2018-09-13
Michael van der Woude [IONISOS]
SpineJack? Preparation Kit 5.0mm2018-09-13
Michael van der Woude [IONISOS]
SpineJack? Preparation Kit 4.2mm2018-09-13
Michael van der Woude [IONISOS]
Parietex2018-04-27
Michael van der Woude [IONISOS]
Parietex Optimized Composite Mesh (PCOX)2018-04-27
Michael van der Woude [IONISOS]
Parietex Optimized Composite Mesh (PCO-OSX)2018-04-27
Michael van der Woude [IONISOS]
Parietex Optimized Composite Mesh (PCO-FX)2018-04-27
Michael van der Woude [IONISOS]
Parietex Composite2018-04-27
Michael van der Woude [IONISOS]
Parietex Composite (PCO-OS)2018-04-27
STERYLENE [IONISOS]
Cair Drive (EL500) , Neutaclear (EL200)2017-12-21
STERYLENE [IONISOS]
SEAL ONE Radial compression device2017-12-21
STERYLENE [IONISOS]
MYSHELL LITE2017-12-21
STERYLENE [IONISOS]
Vectec disposable trocars and laparoscopic accessories2017-12-21
STERYLENE [IONISOS]
DOLPHIN Inflation Device2017-12-21
STERYLENE [IONISOS]
Inflation System2017-12-21
STERYLENE [IONISOS]
FLAMINGO Inflation Device2017-12-21
Michael van de Woude [IONISOS]
iCare2017-11-30
Michael van de Woude [IONISOS]
iCare tonometer2017-11-30
Michael van de Woude [IONISOS]
iCare2017-11-30
Michael van de Woude [IONISOS]
iCare tonometer2017-11-30
Michael van der Woude [IONISOS]
Versatex? Monofilament Mesh2015-06-03
Michael van der Woude [IONISOS]
Masterflow(TM) Injection System2015-05-05
Michael van der Woude [IONISOS]
Masterflow(TM) Injection System2015-05-05

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