Widex A S

FDA Filings

This page includes the latest FDA filings for Widex 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 Number3010875554
FEI Number3010875554
NameWidex Eesti OU
Owner & OperatorWidex A/S
Contact AddressNymoellevej 6 --
Lynge DK-84 Region Hovedstaden DK-3540 DK
Official Correspondent
  • Kristine Klitgaard Pedersen
  • 45-443-55600-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressSaeveski Str. 10A
Tallinn Harjumaa, 11214 EE
Establishment TypeExport Device to the United States But Perform No Other Operation on Device



Registration Number8021514
FEI Number3003557127
NameJon Schirado
Owner & OperatorWidex A/S
Contact AddressNymoellevej 6 --
Lynge DK-84 Region Hovedstaden DK-3540 DK
Official Correspondent
  • Kristine Klitgaard Pedersen
  • 45-443-55600-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressATRIA Corporate Center, Suite W125 3033 Campus Drive
Plymouth, MN 55441 US
Establishment TypeManufacture Medical Device



Registration Number3008974030
FEI Number3008974030
NameWidex Regional Operation Center EMEA Sp. z.o.o.
Owner & OperatorWidex A/S
Contact AddressNymoellevej 6 --
Lynge DK-84 Region Hovedstaden DK-3540 DK
Official Correspondent
  • Kristine Klitgaard Pedersen
  • 45-443-55600-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressPrologis Park Wroclaw III UI. Graniczna DC1
WROCLAW Dolnoslaskie, 54-610 PL
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Widex A/S
Widex 210290172024-11-06
Widex A/S
Widex 210289442024-11-06
Widex A/S
Widex 210289432024-11-06
Widex A/S
Widex 210289482024-11-06
Widex A/S
Widex 210289402024-11-06
Widex A/S
Widex 210289472024-11-06
Widex A/S
Widex 210289422024-11-06
Widex A/S
Widex 210289452024-11-06
Widex A/S
Widex 210289462024-11-06
Widex A/S
Widex 210289752024-11-06
Widex A/S
Widex 210289962024-11-06
Widex A/S
Widex 210290122024-11-06
Widex A/S
Widex 210290002024-11-06
Widex A/S
Widex 210289792024-11-06
Widex A/S
Widex 210289832024-11-06
Widex A/S
Widex 210290042024-11-06
Widex A/S
Widex 210289922024-11-06
Widex A/S
Widex 210289872024-11-06
Widex A/S
Widex 210290082024-11-06
Widex A/S
Widex 210289762024-11-06
Widex A/S
Widex 210289972024-11-06
Widex A/S
Widex 210290012024-11-06
Widex A/S
Widex 210290132024-11-06
Widex A/S
Widex 210289802024-11-06
Widex A/S
Widex 210289842024-11-06
Widex A/S
Widex 210290052024-11-06
Widex A/S
Widex 210289932024-11-06
Widex A/S
Widex 210289882024-11-06
Widex A/S
Widex 210290092024-11-06
Widex A/S
Widex 210289772024-11-06
Widex A/S
Widex 210289982024-11-06
Widex A/S
Widex 210290022024-11-06
Widex A/S
Widex 210290142024-11-06
Widex A/S
Widex 210289812024-11-06
Widex A/S
Widex 210289852024-11-06
Widex A/S
Widex 210290062024-11-06
Widex A/S
Widex 210289942024-11-06
Widex A/S
Widex 210290102024-11-06
Widex A/S
Widex 210289782024-11-06
Widex A/S
Widex 210289892024-11-06
Widex A/S
Widex 210289992024-11-06
Widex A/S
Widex 210290032024-11-06
Widex A/S
Widex 210290152024-11-06
Widex A/S
Widex 210289822024-11-06
Widex A/S
Widex 210289862024-11-06
Widex A/S
Widex 210290072024-11-06
Widex A/S
Widex 210289952024-11-06
Widex A/S
Widex 210289902024-11-06
Widex A/S
Widex 210233412024-11-06
Widex A/S
WIDEX 210410012024-09-23
Widex A/S
Widex 210410002024-09-23
Widex A/S
WIDEX 210283482024-07-08
Widex A/S
WIDEX 210419792024-06-21
Widex A/S
WIDEX 210419752024-06-21
Widex A/S
WIDEX 210419742024-06-21
Widex A/S
Coselgi 210380072024-05-08
Widex A/S
WIDEX 210380042024-05-08
Widex A/S
WIDEX 210380032024-05-08
Widex A/S
WIDEX 109854272024-04-08
Widex A/S
WIDEX 109854352024-04-01
Widex A/S
WIDEX 109854332024-04-01
Widex A/S
WIDEX 109854302024-04-01
Widex A/S
WIDEX 109854292024-04-01
Widex A/S
WIDEX 109854262024-04-01
Widex A/S
WIDEX 109854252024-04-01
Widex A/S
WIDEX 109854242024-04-01
Widex A/S
WIDEX 109854232024-04-01
Widex A/S
WIDEX 109854222024-04-01
Widex A/S
WIDEX 109854212024-04-01
Widex A/S
WIDEX 109854202024-04-01
Widex A/S
WIDEX 109854192024-04-01
Widex A/S
WIDEX 109854182024-04-01
Widex A/S
WIDEX 109854172024-04-01
Widex A/S
WIDEX 109854162024-04-01
Widex A/S
WIDEX 109854152024-04-01
Widex A/S
WIDEX 109895872024-04-01
Widex A/S
WIDEX 109842462024-03-25
Widex A/S
WIDEX 109842452024-03-25
Widex A/S
WIDEX 109842442024-03-25
Widex A/S
WIDEX 109842432024-03-25
Widex A/S
WIDEX 109842422024-03-25
Widex A/S
WIDEX 109842412024-03-25
Widex A/S
WIDEX 109842402024-03-25
Widex A/S
WIDEX 109842342024-03-25
Widex A/S
WIDEX 109842332024-03-25
Widex A/S
WIDEX 109842322024-03-25
Widex A/S
WIDEX 109842312024-03-25
Widex A/S
WIDEX 109842302024-03-25
Widex A/S
WIDEX 109842292024-03-25
Widex A/S
WIDEX 109842282024-03-25
Widex A/S
WIDEX 109842272024-03-25
Widex A/S
WIDEX 109842262024-03-25
Widex A/S
WIDEX 109842252024-03-25
Widex A/S
WIDEX 109842242024-03-25
Widex A/S
WIDEX 109842232024-03-25
Widex A/S
WIDEX 109842222024-03-25
Widex A/S
WIDEX 109842212024-03-25
Widex A/S
WIDEX 109721712024-03-25
Widex A/S
WIDEX 109842202024-03-25
Widex A/S
WIDEX 109855972024-03-25
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Widex Zen2Go2011-09-01
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Widex IE-ZEN2011-09-01
Widex Eesti OU [Widex A/S]
Widex Zen2Go2011-09-01
Widex Eesti OU [Widex A/S]
Widex IE-ZEN2011-09-01
Jon Schirado [Widex A/S]
Widex Zen2Go2011-09-01
Jon Schirado [Widex A/S]
Widex IE-ZEN2011-09-01
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Widex ZEN2011-04-08
Widex Eesti OU [Widex A/S]
Widex ZEN2011-04-08
Jon Schirado [Widex A/S]
Widex ZEN2011-04-08
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Widex UNIQUE, BTE, ITE, CIC, RIC, RITE2011-04-08
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Widex Mind, BTE, ITE, CIC2011-04-08
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Widex MOMENT ITE, CIC, RIC, RITE2011-04-08
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Widex EVOKE, BTE, RIC, RITE, ITE, CIC2011-04-08
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Widex Dream, BTE, ITE, CIC, RIC, RITE2011-04-08
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Widex Clear, BTE, ITE, CIC, RIC, RITE2011-04-08
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Widex Beyond, RIC2011-04-08
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Regal, RIC, RITE2011-04-08
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Regal 2, RIC, RITE2011-04-08
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
HCS Dream, BTE, ITE, CIC, RIC, RITE2011-04-08
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
EarQ UNIQUE, BTE, ITE, CIC, RIC, RITE2011-04-08
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
EarQ EVOKE, BTE, ITE, CIC, RIC, RITE2011-04-08
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
EarQ Beyond, RIC2011-04-08
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Coselgi Melodia2011-04-08
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Audigy AGXw Evoke, RIC, RITE2011-04-08
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Audigy AGXW Unique, BTE, ITE, CIC, RIC, RITE2011-04-08
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Audigy AGXW Dream, BTE, ITE, CIC, RIC, RITE2011-04-08
Widex Eesti OU [Widex A/S]
Widex UNIQUE, BTE, ITE, CIC, RIC, RITE2011-04-08
Widex Eesti OU [Widex A/S]
Widex Mind, BTE, ITE, CIC2011-04-08
Widex Eesti OU [Widex A/S]
Widex MOMENT ITE, CIC, RIC, RITE2011-04-08
Widex Eesti OU [Widex A/S]
Widex EVOKE, BTE, RIC, RITE, ITE, CIC2011-04-08
Widex Eesti OU [Widex A/S]
Widex Dream, BTE, ITE, CIC, RIC, RITE2011-04-08
Widex Eesti OU [Widex A/S]
Widex Clear, BTE, ITE, CIC, RIC, RITE2011-04-08
Widex Eesti OU [Widex A/S]
Widex Beyond, RIC2011-04-08
Widex Eesti OU [Widex A/S]
Regal, RIC, RITE2011-04-08
Widex Eesti OU [Widex A/S]
Regal 2, RIC, RITE2011-04-08
Widex Eesti OU [Widex A/S]
HCS Dream, BTE, ITE, CIC, RIC, RITE2011-04-08
Widex Eesti OU [Widex A/S]
EarQ UNIQUE, BTE, ITE, CIC, RIC, RITE2011-04-08
Widex Eesti OU [Widex A/S]
EarQ EVOKE, BTE, ITE, CIC, RIC, RITE2011-04-08
Widex Eesti OU [Widex A/S]
EarQ Beyond, RIC2011-04-08
Widex Eesti OU [Widex A/S]
Coselgi Melodia2011-04-08
Widex Eesti OU [Widex A/S]
Audigy AGXw Evoke, RIC, RITE2011-04-08
Widex Eesti OU [Widex A/S]
Audigy AGXW Unique, BTE, ITE, CIC, RIC, RITE2011-04-08
Widex Eesti OU [Widex A/S]
Audigy AGXW Dream, BTE, ITE, CIC, RIC, RITE2011-04-08
Jon Schirado [Widex A/S]
Widex UNIQUE, BTE, ITE, CIC, RIC, RITE2011-04-08
Jon Schirado [Widex A/S]
Widex Mind, BTE, ITE, CIC2011-04-08
Jon Schirado [Widex A/S]
Widex MOMENT ITE, CIC, RIC, RITE2011-04-08
Jon Schirado [Widex A/S]
Widex EVOKE, BTE, RIC, RITE, ITE, CIC2011-04-08
Jon Schirado [Widex A/S]
Widex Dream, BTE, ITE, CIC, RIC, RITE2011-04-08
Jon Schirado [Widex A/S]
Widex Clear, BTE, ITE, CIC, RIC, RITE2011-04-08
Jon Schirado [Widex A/S]
Widex Beyond, RIC2011-04-08
Jon Schirado [Widex A/S]
Regal, RIC, RITE2011-04-08
Jon Schirado [Widex A/S]
Regal 2, RIC, RITE2011-04-08
Jon Schirado [Widex A/S]
HCS Dream, BTE, ITE, CIC, RIC, RITE2011-04-08
Jon Schirado [Widex A/S]
EarQ UNIQUE, BTE, ITE, CIC, RIC, RITE2011-04-08
Jon Schirado [Widex A/S]
EarQ EVOKE, BTE, ITE, CIC, RIC, RITE2011-04-08
Jon Schirado [Widex A/S]
EarQ Beyond, RIC2011-04-08
Jon Schirado [Widex A/S]
Coselgi Melodia2011-04-08
Jon Schirado [Widex A/S]
Audigy AGXw Evoke, RIC, RITE2011-04-08
Jon Schirado [Widex A/S]
Audigy AGXW Unique, BTE, ITE, CIC, RIC, RITE2011-04-08
Jon Schirado [Widex A/S]
Audigy AGXW Dream, BTE, ITE, CIC, RIC, RITE2011-04-08
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Widex Vital, BTE, ITE, CIC2001-10-19
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Widex Senso, BTE2001-10-19
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Widex Menu, BTE, ITE, CIC2001-10-19
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Widex Bravo, BTE2001-10-19
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Widex Bravissimo, BTE2001-10-19
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Widex Baby, RITE2001-10-19
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Coselgi Vivace, BTE, ITE, CIC2001-10-19
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Coselgi Arte, BTE, ITE, CIC2001-10-19
Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]
Coselgi Armonia, BTE, ITE, CIC2001-10-19
Widex Eesti OU [Widex A/S]
Widex Vital, BTE, ITE, CIC2001-10-19
Widex Eesti OU [Widex A/S]
Widex Senso, BTE2001-10-19
Widex Eesti OU [Widex A/S]
Widex Menu, BTE, ITE, CIC2001-10-19
Widex Eesti OU [Widex A/S]
Widex Bravo, BTE2001-10-19
Widex Eesti OU [Widex A/S]
Widex Bravissimo, BTE2001-10-19
Widex Eesti OU [Widex A/S]
Widex Baby, RITE2001-10-19
Widex Eesti OU [Widex A/S]
Coselgi Vivace, BTE, ITE, CIC2001-10-19
Widex Eesti OU [Widex A/S]
Coselgi Arte, BTE, ITE, CIC2001-10-19
Widex Eesti OU [Widex A/S]
Coselgi Armonia, BTE, ITE, CIC2001-10-19
Jon Schirado [Widex A/S]
Widex Vital, BTE, ITE, CIC2001-10-19
Jon Schirado [Widex A/S]
Widex Senso, BTE2001-10-19
Jon Schirado [Widex A/S]
Widex Menu, BTE, ITE, CIC2001-10-19
Jon Schirado [Widex A/S]
Widex Bravo, BTE2001-10-19
Jon Schirado [Widex A/S]
Widex Bravissimo, BTE2001-10-19
Jon Schirado [Widex A/S]
Widex Baby, RITE2001-10-19
Jon Schirado [Widex A/S]
Coselgi Vivace, BTE, ITE, CIC2001-10-19
Jon Schirado [Widex A/S]
Coselgi Arte, BTE, ITE, CIC2001-10-19
Jon Schirado [Widex A/S]
Coselgi Armonia, BTE, ITE, CIC2001-10-19

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
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2020022027346Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyPACKAGING MATERIALS HS CODE 42023290 48192 0008 PCS
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20190810167Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyPACKAGING MATERIALS 259 PACKAGES STOWED ON 8 PALLETS259 PCS
20190704848Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyPACKAGING MATERIALS 259 CARTONS LOADED ON 8 P ALLETS259 PCS
201906272203Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyPACKAGING MATERIALS 259 CARTONS LOADED ON 8 P ALLETS259 PCS
201906199948Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyPACKAGING MATERIALS HS CODE 42023290 48192 000259 PCS

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