Ypsomed Ag

FDA Filings

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

FDA Registration(s)
Registration Number3005170966
FEI Number3005170966
NameTodd Durniak
Owner & OperatorYPSOMED AG
Contact AddressBRUNNMATTSTRASSE 6 --
BURGDORF, BERN CH-NOTA CH-3401 CH
Official Correspondent
  • Verena - Baer
  • 41-34-424-3534
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address32 Wilson road
Concord, MA 01742 US
Establishment TypeManufacture Medical Device

Registration Number3002806818
FEI Number3002806818
NameTodd Durniak
Owner & OperatorYPSOMED AG
Contact AddressBRUNNMATTSTRASSE 6 --
BURGDORF, BERN CH-NOTA CH-3401 CH
Official Correspondent
  • Verena - Baer
  • 41-34-424-3534
US Agent
Importing Logistics Registration
ImporterBigfoot Biomedical, Inc.
Address1561 Buckeye Drive
Milpitas, CA 95035 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address32 Wilson road
Concord, MA 01742 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
Ypsomed AG
 Penfine Classic Pen Needles 7000229182023-06-27
Ypsomed AG
 Penfine Classic Pen Needles 7000229172023-06-27
Ypsomed AG
 Penfine Classic Pen Needles 7000229162023-06-27
Ypsomed AG
 Clickfine Pen Needles 7000215422022-09-02
Ypsomed AG
 Clickfine AutoProtect 7000148952022-05-05
Ypsomed AG
 Clickfine pen needles 7000199272021-11-09
Ypsomed AG
 Soft-Release-Micro S80812020-09-23
Ypsomed AG
 Soft-Release-Micro S80512020-09-23
Ypsomed AG
 Soft-Release-Micro S60812020-09-23
Ypsomed AG
 Soft-Release-Micro S60512020-09-23
Ypsomed AG
 Soft-Release-Micro S30812020-09-23
Ypsomed AG
 Soft-Release-Micro S30512020-09-23
Ypsomed AG
 Orbit®Inserter 7000120602018-03-29
Ypsomed AG
 Orbit soft O4291OB2018-03-29
Ypsomed AG
 Soft-Release-O S80612018-03-29
Ypsomed AG
 Soft-Release-O S60912018-03-29
Ypsomed AG
 Soft-Release-O S60612018-03-29
Ypsomed AG
 Soft-Release-O S80912018-03-29
Ypsomed AG
 Soft-Release-O S100612018-03-29
Ypsomed AG
 Soft-Release-O S100912018-03-29
Ypsomed AG
 Soft-Release-O S30912018-03-29
Ypsomed AG
 Soft-Release-O S30612018-03-29
Ypsomed AG
Clickfine Pen Needle, Penfine Classic Pen Needle2017-10-11
YPSOMED AG
Orbit Inserter2017-07-26
YPSOMED AG
Orbit Infusion Set2016-04-12
YPSOMED AG
Clickfine AutoProtect Pen Needle2015-11-18
YPSOMED AG
Clickfine Pen Needle, Penfine Classic Pen Needle (other Trade Names Anticipated)2015-06-09
YPSOMED AG
CLICKFINE PEN NEEDLE2013-07-05
YPSOMED AG
CLICKFINE AUTOPROTECT PEN NEEDLE2013-07-05
YPSOMED AG
ORBIT INFUSION SET2013-03-19
YPSOMED AG
CLICKFINE AUTOPROTECT PEN NEEDLE2012-01-26
YPSOMED AG
CLICKFINE PEN NEEDLE2010-11-23
YPSOMED AG
CLICKFINE PEN NEEDLE2010-04-30

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020072555662Veracruz,Mexico -> New Orleans, LouisianaINSULIN ADMINISTRATION DEVICE18 PAL
2020063049809Stadersand,Federal Republic of Germany -> Norfolk, VirginiaSYRINGES31 PKG
2018122228Anvers,Belgium -> Norfolk, VirginiaINJECTIONS41 BOX
2018051029438Sines,Portugal -> Long Beach, CaliforniaLOADED ON 27 PALLETS DOSING MECHANISM CARTRID GES HOLDER PRINTED PEN CAP BLUE NET WEIGHT: 4 724.812 KGS H.S. CODE: 9018310027 CTN
2018041928Anvers,Belgium -> Norfolk, VirginiaS.T.C. INJECTIONS HS-CODE 90183100116 PKG
2018041928Anvers,Belgium -> Norfolk, VirginiaS.T.C. INJECTIONS HS-CODE 90183100116 PKG
2018041928Anvers,Belgium -> Norfolk, VirginiaS.T.C. INJECTIONS HS-CODE 90183100116 PKG
2018031421422Anvers,Belgium -> Norfolk, VirginiaINJECTIONS41 PKG
2018030943311Anvers,Belgium -> Norfolk, VirginiaINJECTIONS41 PKG
2018030851157Anvers,Belgium -> Norfolk, VirginiaINJECTIONS41 PKG
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