Widex Regional Operation Center Emea Sp Z O O

FDA Filings

This page includes the latest FDA filings for Widex Regional Operation Center Emea Sp Z O O. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3008974030
• FEI Number: 3008974030
• Name: Widex Regional Operation Center EMEA Sp. z.o.o.
• Owner & Operator: Widex A/S
• Contact Address: Nymoellevej 6 --; Lynge DK-84 Region Hovedstaden DK-3540 DK
• Official Correspondent:
  • Kristine Klitgaard Pedersen
  • 45-443-55600-x
• US Agent:
  • Jon Schirado
  • Sivantos, Inc.
  • 763 4774677
  • jon.schirado@sivantos.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Prologis Park Wroclaw III UI. Graniczna DC1; WROCLAW Dolnoslaskie, 54-610 PL
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K110973 | KLW Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Widex Zen2Go	2011-09-01
PMN K110973 | KLW Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Widex IE-ZEN	2011-09-01
PMN K080955 | KLW Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Widex ZEN	2011-04-08
PMN DEN100025 | OSM Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Widex UNIQUE, BTE, ITE, CIC, RIC, RITE	2011-04-08
PMN DEN100025 | OSM Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Widex Mind, BTE, ITE, CIC	2011-04-08
PMN DEN100025 | OSM Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Widex MOMENT ITE, CIC, RIC, RITE	2011-04-08
PMN DEN100025 | OSM Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Widex EVOKE, BTE, RIC, RITE, ITE, CIC	2011-04-08
PMN DEN100025 | OSM Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Widex Dream, BTE, ITE, CIC, RIC, RITE	2011-04-08
PMN DEN100025 | OSM Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Widex Clear, BTE, ITE, CIC, RIC, RITE	2011-04-08
PMN DEN100025 | OSM Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Widex Beyond, RIC	2011-04-08
PMN DEN100025 | OSM Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Regal, RIC, RITE	2011-04-08
PMN DEN100025 | OSM Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Regal 2, RIC, RITE	2011-04-08
PMN DEN100025 | OSM Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	HCS Dream, BTE, ITE, CIC, RIC, RITE	2011-04-08
PMN DEN100025 | OSM Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	EarQ UNIQUE, BTE, ITE, CIC, RIC, RITE	2011-04-08
PMN DEN100025 | OSM Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	EarQ EVOKE, BTE, ITE, CIC, RIC, RITE	2011-04-08
PMN DEN100025 | OSM Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	EarQ Beyond, RIC	2011-04-08
PMN DEN100025 | OSM Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Coselgi Melodia	2011-04-08
PMN DEN100025 | OSM Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Audigy AGXw Evoke, RIC, RITE	2011-04-08
PMN DEN100025 | OSM Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Audigy AGXW Unique, BTE, ITE, CIC, RIC, RITE	2011-04-08
PMN DEN100025 | OSM Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Audigy AGXW Dream, BTE, ITE, CIC, RIC, RITE	2011-04-08
ESD Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Widex Vital, BTE, ITE, CIC	2001-10-19
ESD Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Widex Senso, BTE	2001-10-19
ESD Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Widex Menu, BTE, ITE, CIC	2001-10-19
ESD Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Widex Bravo, BTE	2001-10-19
ESD Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Widex Bravissimo, BTE	2001-10-19
ESD Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Widex Baby, RITE	2001-10-19
ESD Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Coselgi Vivace, BTE, ITE, CIC	2001-10-19
ESD Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Coselgi Arte, BTE, ITE, CIC	2001-10-19
ESD Widex Regional Operation Center EMEA Sp. z.o.o. [Widex A/S]	Coselgi Armonia, BTE, ITE, CIC	2001-10-19