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 Number: 8021545
• FEI Number: 1000477110
• Name: UNOMEDICAL A/S
• Owner & Operator: ConvaTec Inc.
• Contact Address: 7900 Triad Center Drive Suite 400; Greensboro NC 27409 US
• Official Correspondent:
  • Matt Walenciak
  • x-908-3779293-x
• US Agent:
  • Matthew Walenciak
  • ConvaTec Inc.
  • 908 3779293
  • matthew.walenciak@convatec.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Aaholmvej 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	Device	Date
GUDID 05705244026292 Unomedical A/S	inset™ n/a	2024-05-10
GUDID 05705244026261 Unomedical A/S	inset™ n/a	2024-05-10
GUDID 05705244025271 Unomedical A/S	contact detach	2024-04-30
GUDID 05705244026056 Unomedical A/S	Autosoft™ XC N/A	2023-06-21
GUDID 05705244026025 Unomedical A/S	Autosoft™ XC	2023-06-21
GUDID 05705244025998 Unomedical A/S	Autosoft™ XC N/A	2023-06-21
GUDID 05705244025547 Unomedical A/S	Medtronic Extended N/A	2023-06-09
GUDID 05705244025516 Unomedical A/S	Medtronic Extended N/A	2023-06-09
GUDID 05705244025486 Unomedical A/S	Medtronic Extended N/A	2023-06-09
GUDID 05705244025455 Unomedical A/S	Medtronic Extended N/A	2023-06-09
GUDID 05705244025424 Unomedical A/S	Medtronic Extended N/A	2023-06-09
GUDID 05705244025394 Unomedical A/S	Medtronic Extended N/A	2023-06-09
GUDID 05705244025363 Unomedical A/S	Medtronic Extended N/A	2023-06-09
GUDID 05705244025332 Unomedical A/S	Medtronic Extended N/A	2023-06-09
GUDID 05705244023567 Unomedical A/S	Medtronic Extended N/A	2023-06-09
GUDID 05705244023505 Unomedical A/S	Medtronic Extended N/A	2023-06-09
GUDID 05705244023475 Unomedical A/S	Medtronic Extended N/A	2023-06-09
GUDID 05705244023444 Unomedical A/S	Medtronic Extended N/A	2023-06-09
GUDID 05705244023413 Unomedical A/S	Medtronic Extended N/A	2023-06-09
GUDID 05705244023383 Unomedical A/S	Medtronic Extended N/A	2023-06-09
GUDID 05705244023598 Unomedical A/S	Medtronic Extended N/A	2023-06-01
GUDID 05705244023543 Unomedical A/S	Medtronic Extended	2023-06-01
GUDID 05705244023352 Unomedical A/S	Medtronic Extended	2022-07-07
GUDID 05705244023321 Unomedical A/S	Medtronic Extended	2022-07-07
GUDID 05705244023291 Unomedical A/S	Medtronic Extended	2022-07-07
GUDID 05705244023260 Unomedical A/S	Medtronic Extended	2022-07-07
GUDID 05705244023239 Unomedical A/S	Medtronic Extended	2022-07-07
GUDID 05705244023208 Unomedical A/S	Medtronic Extended	2022-07-07
GUDID 05705244023178 Unomedical A/S	Medtronic Extended	2022-07-07
GUDID 05705244023147 Unomedical A/S	Medtronic Extended	2022-07-07
GUDID 05705244023116 Unomedical A/S	Medtronic Extended	2022-07-07
GUDID 05705244023086 Unomedical A/S	Medtronic Extended	2022-07-07
GUDID 05705244023055 Unomedical A/S	Medtronic Extended	2022-07-07
GUDID 05705244023024 Unomedical A/S	Medtronic Extended	2022-07-07
GUDID 05705244022997 Unomedical A/S	Medtronic Extended	2022-07-07
GUDID 05705244022966 Unomedical A/S	Medtronic Extended	2022-07-07
GUDID 05705244022935 Unomedical A/S	Medtronic Extended	2022-07-07
GUDID 05705244022904 Unomedical A/S	Medtronic Extended	2022-07-07
GUDID 05705244022874 Unomedical A/S	Medtronic Extended	2022-07-07
GUDID 05705244022843 Unomedical A/S	Medtronic Extended	2022-07-07
GUDID 05705244022812 Unomedical A/S	Medtronic Extended	2022-07-07
GUDID 05705244022782 Unomedical A/S	Medtronic Extended	2022-07-07
GUDID 05705244022751 Unomedical A/S	Medtronic Extended	2022-07-07
GUDID 05705244022720 Unomedical A/S	Medtronic Extended	2022-07-07
GUDID 05705244022690 Unomedical A/S	Medtronic Extended	2022-07-07
GUDID 05705244022669 Unomedical A/S	Medtronic Extended	2022-07-07
GUDID 05705244020177 Unomedical A/S	Minimed™ Mio™ NA	2021-12-06
GUDID 05705244020146 Unomedical A/S	Minimed™ Mio™ NA	2021-12-06
GUDID 05705244020054 Unomedical A/S	Minimed™ Mio™ NA	2021-12-06
GUDID 05705244020023 Unomedical A/S	Minimed™ Mio™ NA	2021-12-06
GUDID 05705244019997 Unomedical A/S	Minimed™ Mio™ NA	2021-12-06
GUDID 05705244019966 Unomedical A/S	Minimed™ Mio™ NA	2021-12-06
GUDID 05705244019935 Unomedical A/S	Minimed™ Mio™ NA	2021-12-06
GUDID 05705244019904 Unomedical A/S	Minimed™ Mio™ NA	2021-12-06
GUDID 05705244019454 Unomedical A/S	MiniMed Sure-T	2021-11-19
GUDID 05705244019423 Unomedical A/S	MiniMed Sure-T	2021-11-19
GUDID 05705244019393 Unomedical A/S	MiniMed Sure-T	2021-11-19
GUDID 05705244019362 Unomedical A/S	MiniMed Sure-T	2021-11-19
GUDID 05705244019331 Unomedical A/S	MiniMed Sure-T	2021-11-19
GUDID 05705244019300 Unomedical A/S	MiniMed Sure-T	2021-11-19
GUDID 05705244019270 Unomedical A/S	MiniMed Sure-T	2021-11-19
GUDID 05705244018105 Unomedical A/S	Minimed Quick-set	2021-11-19
GUDID 05705244018075 Unomedical A/S	Minimed Quick-set	2021-11-19
GUDID 05705244018044 Unomedical A/S	Minimed Quick-set	2021-11-19
GUDID 05705244017986 Unomedical A/S	Minimed Quick-set	2021-11-19
GUDID 05705244017955 Unomedical A/S	Minimed Quick-set	2021-11-19
GUDID 05705244017924 Unomedical A/S	Minimed Quick-set	2021-11-19
GUDID 05705244017863 Unomedical A/S	Minimed Quick-set	2021-11-19
GUDID 05705244017832 Unomedical A/S	Minimed Quick-set	2021-11-19
GUDID 05705244017801 Unomedical A/S	Minimed Quick-set	2021-11-19
GUDID 05705244017740 Unomedical A/S	Minimed Quick-set	2021-11-19
GUDID 05705244017719 Unomedical A/S	Minimed Quick-set	2021-11-19
GUDID 05705244017689 Unomedical A/S	Minimed Quick-set	2021-11-19
GUDID 05705244017627 Unomedical A/S	Minimed Quick-set	2021-11-19
GUDID 05705244017597 Unomedical A/S	Minimed Quick-set	2021-11-19
GUDID 05705244017566 Unomedical A/S	minimed Quick-set	2021-11-19
GUDID 05705244017504 Unomedical A/S	Minimed Quick-set	2021-11-19
GUDID 05705244017474 Unomedical A/S	Minimed Quick-set	2021-11-19
GUDID 05705244017443 Unomedical A/S	Minimed Quick-set	2021-11-19
GUDID 05705244017382 Unomedical A/S	Minimed Quick-set	2021-11-19
GUDID 05705244017351 Unomedical A/S	Minimed Quick-set	2021-11-19
GUDID 05705244017320 Unomedical A/S	Minimed Quick-set	2021-11-19
GUDID 05705244025240 Unomedical A/S	inset™ N/A	2021-10-27
GUDID 05705244025219 Unomedical A/S	inset™ N/A	2021-10-27
PMN K210544 Unomedical A/S	Medtronic Extended Infusion Set	2021-07-16
GUDID 05705244022393 Unomedical A/S	inset™ N/A	2021-06-28
GUDID 05705244025189 Unomedical A/S	Mio Advance	2021-02-11
GUDID 05705244025127 Unomedical A/S	Minimed Mio	2021-02-08
GUDID 05705244025097 Unomedical A/S	Minimed Mio	2021-02-08
GUDID 05705244025066 Unomedical A/S	MiniMed Sure-T	2021-02-08
GUDID 05705244025035 Unomedical A/S	MiniMed Silhouette	2021-02-08
GUDID 05705244025004 Unomedical A/S	MiniMed Silhouette	2021-02-08
GUDID 05705244024977 Unomedical A/S	Minimed Quick-set	2021-02-08
GUDID 05705244024946 Unomedical A/S	Minimed Quick-set	2021-02-08
GUDID 05705244024915 Unomedical A/S	Minimed Quick-set	2021-02-08
GUDID 05705244024885 Unomedical A/S	Minimed Quick-set	2021-02-08
GUDID 05705244021853 Unomedical A/S	Mio Advance	2020-06-23
GUDID 05705244021792 Unomedical A/S	Mio Advance	2020-06-23
GUDID 05705244021709 Unomedical A/S	Mio Advance	2020-06-23
GUDID 05705244018914 Unomedical A/S	Mio Advance	2020-05-25
GUDID 05705244018884 Unomedical A/S	Mio Advance	2020-05-25
PMN K192647 | FPA UNOMEDICAL A/S [ConvaTec Inc.]	neria guard Infusion Set	2019-12-19
PMN K192647 Unomedical A/s	Neria Guard Infusion Set	2019-12-13
FPA UNOMEDICAL A/S [ConvaTec Inc.]	YpsoPump Inset	2019-08-28
FPA UNOMEDICAL A/S [ConvaTec Inc.]	MiniMed? Mio? 30	2019-08-28
FPA UNOMEDICAL A/S [ConvaTec Inc.]	MiniMed? Mio? 30 Infusion Set	2019-08-28
FPA UNOMEDICAL A/S [ConvaTec Inc.]	DANA inset II	2019-08-28
PMN K173879 | FPA UNOMEDICAL A/S [ConvaTec Inc.]	Mio Advance	2018-03-06
PMN K173879 Unomedical A/S	MiniMed Mio Advance Infusion Set	2018-03-05
PMN K162812 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 Set	2017-11-01
PMN K160648 UNOMEDICAL A/S	MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®	2016-08-10
PMN K132142 UNOMEDICAL A/S	NERIA SOFT 90 INFUSION SET	2013-10-08
PMN K120337 UNOMEDICAL A/S	I-PORT ADVANCE INJECTION PORT	2012-02-16
PMN K061374 | KZH UNOMEDICAL A/S [ConvaTec Inc.]	t:30	2008-02-08
PMN K061374 | FPA UNOMEDICAL A/S [ConvaTec Inc.]	t:30	2008-02-08
PMN K032854 | FPA UNOMEDICAL A/S [ConvaTec Inc.]	PL Tandem	2008-02-05
PMN K032854 | FPA UNOMEDICAL A/S [ConvaTec Inc.]	Monica	2008-02-05
PMN K032854 | FPA UNOMEDICAL A/S [ConvaTec Inc.]	Autosoft XC	2008-02-05
PMN K002138 | FPK UNOMEDICAL A/S [ConvaTec Inc.]	Varisoft Lock	2008-02-05
PMN K002138 | FPK UNOMEDICAL A/S [ConvaTec Inc.]	Varisoft Leur	2008-02-05
PMN K002138 | FPK UNOMEDICAL A/S [ConvaTec Inc.]	Pureline Comfort	2008-02-05
PMN K002138 | FPA UNOMEDICAL A/S [ConvaTec Inc.]	Varisoft Lock	2008-02-05
PMN K002138 | FPA UNOMEDICAL A/S [ConvaTec Inc.]	Varisoft Leur	2008-02-05
PMN K002138 | FPA UNOMEDICAL A/S [ConvaTec Inc.]	Pureline Comfort	2008-02-05
PMN K070430 UNOMEDICAL A/S	PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS	2007-04-04
PMN K061374 UNOMEDICAL A/S	INTUITION INFUSION SETS	2006-07-31
PMN K051264 UNOMEDICAL A/S	COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS	2005-09-01
PMN K041545 UNOMEDICAL A/S	CONTACT DETACH	2004-06-30
PMN K040633 UNOMEDICAL A/S	CLICK-ON	2004-04-01
PMN K032854 UNOMEDICAL A/S	UNOMEDICAL MONICA INFUSION SET	2003-10-09

Similar & Related FDA Registered Companies

• UNOMEDICAL A/S INFUSION DEVICES

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091942755	Bremerhaven,Federal Republic of Germany -> Houston, Texas	VARIOUS MATERIALS FOR PRODUCTION OF MEDICAL S UPPLIES	65 PKG
2020091942755	Bremerhaven,Federal Republic of Germany -> Houston, Texas	VARIOUS MATERIALS FOR PRODUCTION OF MEDICAL S UPPLIES	65 PKG
2020091942760	Bremerhaven,Federal Republic of Germany -> Houston, Texas	VARIOUS MATERIALS FOR PRODUCTION OF MEDICAL S UPPLIES	60 PKG
2020091942760	Bremerhaven,Federal Republic of Germany -> Houston, Texas	VARIOUS MATERIALS FOR PRODUCTION OF MEDICAL S UPPLIES	60 PKG
2020091462968	Bremerhaven,Federal Republic of Germany -> Houston, Texas	VARIOUS MATERIALS FOR PRODUCTION OF MEDICAL H S CODE: 391740	29 PKG
2020091242933	Bremerhaven,Federal Republic of Germany -> Houston, Texas	VARIOUS MATERIALS FOR PRODUCTION OF MEDICAL H S CODE: 391740	29 PKG
2020090543146	Bremerhaven,Federal Republic of Germany -> Houston, Texas	VARIOUS MATERIALS FOR PRODUCTION HS 39174000	32 PKG
2020090437360	Bremerhaven,Federal Republic of Germany -> Houston, Texas	ARIOUS MATERIALS FOR PRODUCTION HS:48114190	34 PKG
2020083133090	Bremerhaven,Federal Republic of Germany -> Houston, Texas	VARIOUS MATERIALS FOR PRODUCTION OF MEDICAL S UPPLIES	37 PKG
2020083133091	Bremerhaven,Federal Republic of Germany -> Houston, Texas	VARIOUS MATERIALS FOR PRODUCTION OF MEDICAL S UPPLIES AND INF	62 PKG
2020083133091	Bremerhaven,Federal Republic of Germany -> Houston, Texas	VARIOUS MATERIALS FOR PRODUCTION OF MEDICAL S UPPLIES AND INF	62 PKG