Sonova Usa Inc

FDA Filings

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

Sonova Usa Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Mario Castano
• Sonova Operations Center Vietnam Co., Ltd

FDA Registration(s)

• Registration Number: 3008848788
• FEI Number: 3008848788
• Name: Sonova USA Inc.
• Owner & Operator: Sonova AG
• Contact Address: 28 LAUBISRUETISTRASSE --; STAEFA CH-ZH Zurich 8712 CH
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 444 Commerce Street ; Aurora, IL 60504 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K123450 | KLW Sonova USA Inc. [Sonova AG]	Phonak Virto V	2014-01-06
PMN K123450 | KLW Sonova USA Inc. [Sonova AG]	Phonak Virto M	2014-01-06
PMN K123450 | KLW Sonova USA Inc. [Sonova AG]	Phonak Naida V	2014-01-06
PMN K123450 | KLW Sonova USA Inc. [Sonova AG]	Phonak Naida M	2014-01-06
PMN K123450 | KLW Sonova USA Inc. [Sonova AG]	Phonak Bolero V	2014-01-06
PMN K123450 | KLW Sonova USA Inc. [Sonova AG]	Phonak Bolero M	2014-01-06
PMN K123450 | KLW Sonova USA Inc. [Sonova AG]	Phonak Bolero B	2014-01-06
PMN K123450 | KLW Sonova USA Inc. [Sonova AG]	Phonak Audeo M	2014-01-06
PMN K123450 | KLW Sonova USA Inc. [Sonova AG]	Phonak Audeo B	2014-01-06
OSM Sonova USA Inc. [Sonova AG]	Unitron Vista	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	Unitron Stride	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	Unitron Stride P	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	Unitron Stride P Dura	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	Unitron Remote Plus	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	PilotOne II	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	Phonak Virto V	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	Phonak Virto M	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	Phonak Virto B	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	Phonak Sky V	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	Phonak Sky M	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	Phonak Sky B	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	Phonak Naida V	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	Phonak Naida M	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	Phonak Naida Link	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	Phonak Naida Link CROS	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	Phonak Naida B	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	Phonak CROS B	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	Phonak Brio 4	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	Phonak Brio 3	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	Phonak Bolero V	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	Phonak Bolero M	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	Phonak Bolero B	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	Phonak Audeo M	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	Phonak Audeo B	2011-08-09
OSM Sonova USA Inc. [Sonova AG]	Naida CI Connect	2011-08-09
ESD Sonova USA Inc. [Sonova AG]	Virto M	2006-09-14
ESD Sonova USA Inc. [Sonova AG]	Unitron Vista	2006-09-14
ESD Sonova USA Inc. [Sonova AG]	Unitron Shine Rev	2006-09-14
ESD Sonova USA Inc. [Sonova AG]	Phonak Virto V	2006-09-14
ESD Sonova USA Inc. [Sonova AG]	Phonak Virto B	2006-09-14
ESD Sonova USA Inc. [Sonova AG]	Phonak Brio 3	2006-09-14
ESD Sonova USA Inc. [Sonova AG]	Lyric3	2006-09-14

Related Finance Registrations

NCAGE Code	4B3G7	SONOVA USA INC.
CAGE Code	4B3G7	SONOVA USA INC.
S.A.M. Registration	4B3G7 [75908876]	SONOVA USA INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091836691	Kaohsiung,China (Taiwan) -> Los Angeles, California	800 CNTS 20 PALLETS PHONAK CCS COMBI US INVO ICE NO. 60457872 PO NO. 287955167013474	3200 CTN
2020091836691	Kaohsiung,China (Taiwan) -> Los Angeles, California	20 PALLETS 800 CNTS INVOICE NO. 60458784 PO NO. 287955367013475	3200 CTN
2020091836691	Kaohsiung,China (Taiwan) -> Los Angeles, California	20 PALLETS 800 CNTS INVOICE NO. 60458784 PO NO. 287955367013475	3200 CTN
2020091836691	Kaohsiung,China (Taiwan) -> Los Angeles, California	800 CNTS 20 PALLETS PHONAK CCS COMBI US INVO ICE NO. 60457872 PO NO. 287955167013474 SHIP PED ON BOARD AUGUST 28 2020 SHIPPERS LOAD COU NT AND SEALED	3200 CTN
2020082733014	Kaohsiung,China (Taiwan) -> Los Angeles, California	800 CNTS 20 PALLETS PHONAK CCS COMBI US INV. NO 60456518 PO NO. 2871694670134436	1640 CTN
2020082733014	Kaohsiung,China (Taiwan) -> Los Angeles, California	840 CNTS 21 PALLETS PHONAK CCS COMBI US INV. NO 60456518 PO NO. 2871694670134436 SHIPPED ON BOARD JULY 31 2020 SHIPPERS LOAD COUNT AN D SEALED	1640 CTN
2020082750104	Kaohsiung,China (Taiwan) -> Los Angeles, California	6 PALLETS 240 CNTS UNITRON MOXIR CCS COMBI U S INV. NO. 60456646 PO NO. 288388867013514 1 7 PALLETS 680 CNTS PHONAK CCS COMBI US INV. NO PO NO.	1840 CTN
2020082750104	Kaohsiung,China (Taiwan) -> Los Angeles, California	23 PALLETS 920 CNTS PHONAK CCS COMBI US INV . NO PO NO. SHIPPED ON BOARD AUGUST. 7 2020 SHIPPERS COUNT LOAD AND SEALED	1840 CTN
2020082654322	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	ALCOHOL PADS, GLOVES, MOUTH MASK & HANDGEL	4 PCS
2020080663039	Kaohsiung,China (Taiwan) -> Los Angeles, California	800 CNTS 20 PALLETS PHONAK CCS COMBI US INVO ICE NO. 60455830 PO NO. 287045267013405	1640 CTN
2020080663039	Kaohsiung,China (Taiwan) -> Los Angeles, California	840 CNTS 21 PALLETS PHONAK CCS COMBI US INVO ICE NO. 60455830 PO NO. 287045267013405 SHIP PED ON BOARD JULY 17 2020 SHIPPERS COUND LOAD AND SEALED	1640 CTN
2020080416136	Kaohsiung,China (Taiwan) -> Los Angeles, California	800 CNTS 20 PALLETS PHONAK CCS COMBI US INVO ICE NO. 60454450 PO NO. 286737867013391 SHIP PED ON BOARD JULY 3 2020 SHIPPERS COUNT LOAD AND SEALED	800 CTN
2020072348668	Kaohsiung,China (Taiwan) -> Los Angeles, California	800 CNTS 20 PALLETS PHONAK CCS COMBI US INVO ICE NO. 60454450 PO NO. 286737867013391 SHIP PED ON BOARD JULY 3 2020 SHIPPERS COUNT LOAD AND SEALED	800 CTN
2020071645285	Kaohsiung,China (Taiwan) -> Los Angeles, California	800 CNTS 20 PALLETS PHONAK CCS COMBI US INVO ICE NO. 60454286 PO NO. 285339267013305 SHIP PED ON BOARD JUNE 26 2020 SHIPPERS LOAD COUNT AND SEALED	800 CTN