Unomedical A S

FDA Filings

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

FDA Registration(s)
Registration Number8021545
FEI Number1000477110
NameUNOMEDICAL A/S
Owner & OperatorConvaTec Inc.
Contact Address7900 Triad Center Drive Suite 400
Greensboro NC 27409 US
Official Correspondent
  • Matt Walenciak
  • x-908-3779293-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressAaholmvej 1 - 3
OSTED, LEJRE Region Sjaelland, 4320 DK
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Unomedical A/S
Medtronic Extended Infusion Set2021-07-16
Unomedical A/S
inset™ N/A2021-06-28
Unomedical A/S
Mio Advance 2021-02-11
Unomedical A/S
Minimed Mio 2021-02-08
Unomedical A/S
Minimed Mio 2021-02-08
Unomedical A/S
MiniMed Sure-T 2021-02-08
Unomedical A/S
MiniMed Silhouette 2021-02-08
Unomedical A/S
MiniMed Silhouette 2021-02-08
Unomedical A/S
Minimed Quick-set 2021-02-08
Unomedical A/S
Minimed Quick-set 2021-02-08
Unomedical A/S
Minimed Quick-set 2021-02-08
Unomedical A/S
Minimed Quick-set 2021-02-08
Unomedical A/S
Mio Advance 2020-06-23
Unomedical A/S
Mio Advance 2020-06-23
Unomedical A/S
Mio Advance 2020-06-23
Unomedical A/S
Mio Advance 2020-05-25
Unomedical A/S
Mio Advance 2020-05-25
Unomedical A/S
Mio Advance 2020-05-25
Unomedical A/S
Mio Advance 2020-05-25
Unomedical A/S
Mio Advance 2020-05-25
Unomedical A/S
Neria Guard 2020-05-06
Unomedical A/S
Neria Guard 2020-05-06
Unomedical A/S
Neria Guard 2020-05-06
Unomedical A/S
Neria Guard 2020-05-06
Unomedical A/S
Neria Guard 2020-05-06
Unomedical A/S
Neria Guard 2020-05-06
Unomedical A/S
Neria Guard 2020-05-06
Unomedical A/S
Neria Guard 2020-05-06
Unomedical A/S
Neria Guard 2020-05-06
Unomedical A/S
Neria Guard 2020-05-06
Unomedical A/S
Neria Guard 2020-05-06
Unomedical A/S
Neria Guard 2020-05-06
Unomedical A/S
AutoSoft 90 2020-03-30
Unomedical A/S
AutoSoft 90 2020-03-30
Unomedical A/S
AutoSoft 90 2020-03-30
Unomedical A/S
AutoSoft 90 2020-03-30
Unomedical A/S
AutoSoft 90 2020-03-30
Unomedical A/S
AutoSoft 90 2020-03-30
Unomedical A/S
AutoSoft 90 2020-03-30
Unomedical A/S
AutoSoft 90 2020-03-30
Unomedical A/S
Varisoft 2020-03-26
Unomedical A/S
Varisoft 2020-03-26
Unomedical A/S
Varisoft 2020-03-26
Unomedical A/S
Varisoft 2020-03-26
Unomedical A/S
TruSteel 2020-03-26
Unomedical A/S
TruSteel 2020-03-26
Unomedical A/S
TruSteel 2020-03-26
Unomedical A/S
TruSteel 2020-03-26
Unomedical A/S
AutoSoft 30 2020-03-26
Unomedical A/S
AutoSoft 30 2020-03-26
Unomedical A/S
neria™multi 2020-03-18
Unomedical A/S
neria™multi 2020-03-18
Unomedical A/S
neria™soft 90 cannula 2020-03-18
Unomedical A/S
neria™soft 90 2020-03-18
Unomedical A/S
neria™soft 90 2020-03-18
Unomedical A/S
neria™soft 90 2020-03-18
Unomedical A/S
neria™soft 90 2020-03-18
Unomedical A/S
neria™soft 90 2020-03-18
Unomedical A/S
neria™soft 90 2020-03-18
Unomedical A/S
neria™multi 2020-03-18
Unomedical A/S
neria™multi 2020-03-18
Unomedical A/S
neria™multi 2020-03-18
Unomedical A/S
neria™multi 2020-03-18
Unomedical A/S
neria™multi 2020-03-18
Unomedical A/S
neria™multi 2020-03-18
Unomedical A/S
neria™multi 2020-03-18
Unomedical A/S
neria™multi 2020-03-18
Unomedical A/S
neria™ detach 2020-03-18
Unomedical A/S
neria™ detach 2020-03-18
Unomedical A/S
neria™ detach 2020-03-18
Unomedical A/S
neria™ 2020-03-13
Unomedical A/S
neria™ 2020-03-13
Unomedical A/S
neria™ 2020-03-13
Unomedical A/S
neria™ 2020-03-13
Unomedical A/S
neria™ 2020-03-13
Unomedical A/S
neria™ 2020-03-13
Unomedical A/S
neria™ 2020-03-13
Unomedical A/S
neria™ 2020-03-13
Unomedical A/S
neria™ 2020-03-13
Unomedical A/S
neria™ 2020-03-13
Unomedical A/S
neria™ 2020-03-13
Unomedical A/S
neria™ 2020-03-13
Unomedical A/S
neria™ 2020-03-13
Unomedical A/S
neria™ 2020-03-13
Unomedical A/S
neria™ 2020-03-13
Unomedical A/S
neria™ 2020-03-13
Unomedical A/S
neria™ 2020-03-13
Unomedical A/S
neria™ 2020-03-13
Unomedical A/S
neria™ 2020-03-13
Unomedical A/S
neria™soft 2020-03-12
Unomedical A/S
neria™soft cannula 2020-03-12
Unomedical A/S
neria™soft 2020-03-12
Unomedical A/S
neria™soft cannula 2020-03-12
Unomedical A/S
neria™soft 2020-03-12
Unomedical A/S
neria™soft 2020-03-12
Unomedical A/S
neria™soft 2020-03-12
Unomedical A/S
neria™soft 2020-03-12
Unomedical A/S
neria™soft 2020-03-12
Unomedical A/S
Neria Guard 2020-02-03
Unomedical A/S
Neria Guard 2020-02-03
UNOMEDICAL A/S [ConvaTec Inc.]
neria guard Infusion Set2019-12-19
Unomedical A/s
Neria Guard Infusion Set2019-12-13
Unomedical A/S
neria 2019-10-03
UNOMEDICAL A/S [ConvaTec Inc.]
YpsoPump Inset2019-08-28
UNOMEDICAL A/S [ConvaTec Inc.]
MiniMed? Mio? 302019-08-28
UNOMEDICAL A/S [ConvaTec Inc.]
MiniMed? Mio? 30 Infusion Set2019-08-28
UNOMEDICAL A/S [ConvaTec Inc.]
DANA inset II2019-08-28
UNOMEDICAL A/S [ConvaTec Inc.]
Mio Advance2018-03-06
Unomedical A/S
MiniMed Mio Advance Infusion Set2018-03-05
UNOMEDICAL A/S
Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set2017-11-01
UNOMEDICAL A/S
MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®2016-08-10
UNOMEDICAL A/S
NERIA SOFT 90 INFUSION SET2013-10-08
UNOMEDICAL A/S
I-PORT ADVANCE INJECTION PORT2012-02-16
UNOMEDICAL A/S [ConvaTec Inc.]
t:302008-02-08
UNOMEDICAL A/S [ConvaTec Inc.]
t:302008-02-08
UNOMEDICAL A/S [ConvaTec Inc.]
PL Tandem2008-02-05
UNOMEDICAL A/S [ConvaTec Inc.]
Monica2008-02-05
UNOMEDICAL A/S [ConvaTec Inc.]
Autosoft XC2008-02-05
UNOMEDICAL A/S [ConvaTec Inc.]
Varisoft Lock2008-02-05
UNOMEDICAL A/S [ConvaTec Inc.]
Varisoft Leur2008-02-05
UNOMEDICAL A/S [ConvaTec Inc.]
Pureline Comfort2008-02-05
UNOMEDICAL A/S [ConvaTec Inc.]
Varisoft Lock2008-02-05
UNOMEDICAL A/S [ConvaTec Inc.]
Varisoft Leur2008-02-05
UNOMEDICAL A/S [ConvaTec Inc.]
Pureline Comfort2008-02-05
UNOMEDICAL A/S
PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS2007-04-04
UNOMEDICAL A/S
INTUITION INFUSION SETS2006-07-31
UNOMEDICAL A/S
COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS2005-09-01
UNOMEDICAL A/S
CONTACT DETACH2004-06-30
UNOMEDICAL A/S
UNOMEDICAL MONICA INFUSION SET2003-10-09

Similar & Related FDA Registered Companies

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091942755Bremerhaven,Federal Republic of Germany -> Houston, TexasVARIOUS MATERIALS FOR PRODUCTION OF MEDICAL S UPPLIES65 PKG
2020091942755Bremerhaven,Federal Republic of Germany -> Houston, TexasVARIOUS MATERIALS FOR PRODUCTION OF MEDICAL S UPPLIES65 PKG
2020091942760Bremerhaven,Federal Republic of Germany -> Houston, TexasVARIOUS MATERIALS FOR PRODUCTION OF MEDICAL S UPPLIES60 PKG
2020091942760Bremerhaven,Federal Republic of Germany -> Houston, TexasVARIOUS MATERIALS FOR PRODUCTION OF MEDICAL S UPPLIES60 PKG
2020091462968Bremerhaven,Federal Republic of Germany -> Houston, TexasVARIOUS MATERIALS FOR PRODUCTION OF MEDICAL H S CODE: 39174029 PKG
2020091242933Bremerhaven,Federal Republic of Germany -> Houston, TexasVARIOUS MATERIALS FOR PRODUCTION OF MEDICAL H S CODE: 39174029 PKG
2020090543146Bremerhaven,Federal Republic of Germany -> Houston, TexasVARIOUS MATERIALS FOR PRODUCTION HS 3917400032 PKG
2020090437360Bremerhaven,Federal Republic of Germany -> Houston, TexasARIOUS MATERIALS FOR PRODUCTION HS:4811419034 PKG
2020083133090Bremerhaven,Federal Republic of Germany -> Houston, TexasVARIOUS MATERIALS FOR PRODUCTION OF MEDICAL S UPPLIES37 PKG
2020083133091Bremerhaven,Federal Republic of Germany -> Houston, TexasVARIOUS MATERIALS FOR PRODUCTION OF MEDICAL S UPPLIES AND INF62 PKG
2020083133091Bremerhaven,Federal Republic of Germany -> Houston, TexasVARIOUS MATERIALS FOR PRODUCTION OF MEDICAL S UPPLIES AND INF62 PKG

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