Sonova Ag

FDA Filings

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

FDA Registration(s)
Registration Number3004929038
FEI Number3004929038
NameMario Castano
Owner & OperatorSonova AG
Contact Address28 LAUBISRUETISTRASSE --
STAEFA CH-ZH Zurich 8712 CH
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address444 Commerce Street
Aurora, IL 60504 US
Establishment TypeManufacture Medical Device

Registration Number3005085999
FEI Number3005085999
NameMario Castano
Owner & OperatorSonova AG
Contact Address28 LAUBISRUETISTRASSE --
STAEFA CH-ZH Zurich 8712 CH
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4520 Weaver Parkway
Warrenville, IL 60555 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility

Registration Number3006312495
FEI Number3006312495
NameSonova Operations Center Vietnam Co., Ltd
Owner & OperatorSonova AG
Contact Address28 LAUBISRUETISTRASSE --
STAEFA CH-ZH Zurich 8712 CH
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address#29A, VSIP ST NO.8, VIETNAM SINGAPORE INDUSTRIAL PARK THUAN AN TOWN
BINH DUONG PROVINCE Binh Duong, +84 VN
Establishment TypeManufacture Medical Device

Registration Number3008848788
FEI Number3008848788
NameSonova USA Inc.
Owner & OperatorSonova AG
Contact Address28 LAUBISRUETISTRASSE --
STAEFA CH-ZH Zurich 8712 CH
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address444 Commerce Street
Aurora, IL 60504 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
Sonova AG
 Aura:fit Relate 5.9 058-5267-0592026-01-07
Sonova AG
 Aura:fit AudioNova 5.9 058-5262-0592026-01-07
Sonova AG
 Unitron TrueFit 5.9 088-5019-000582026-01-07
Sonova AG
 TrueFit 5.9 USB 058-5268-0592026-01-07
Sonova AG
 Relate5.0 Platinum ITE 10 NW O 063-6401-01762025-12-29
Sonova AG
 Relate5.0 Gold ITE 10 NW O 063-6400-01762025-12-29
Sonova AG
 Relate5.0 Platinum ITE R 063-6396-01762025-12-29
Sonova AG
 Relate5.0 Gold ITE R 063-6395-01762025-12-29
Sonova AG
 AudioNova S9-10 O 063-6401-01652025-12-29
Sonova AG
 AudioNova S9-D R 063-6396-01652025-12-29
Sonova AG
 AudioNova S7-D R 063-6395-01652025-12-29
Sonova AG
 AudioNova S5-D R 063-6394-01652025-12-29
Sonova AG
 AudioNova S3-D R 063-6393-01652025-12-29
Sonova AG
 AudioNova S1-D R 063-6392-01652025-12-29
Sonova AG
 Vista S9-10 NW O 063-6401-01442025-12-29
Sonova AG
 Vista S7-10 NW O 063-6400-01442025-12-29
Sonova AG
 Vista S5-10 NW O 063-6399-01442025-12-29
Sonova AG
 Vista S3-10 NW O 063-6398-01442025-12-29
Sonova AG
 Vista S1-10 NW O 063-6397-01442025-12-29
Sonova AG
 Vista S9-Dir R 063-6396-01442025-12-29
Sonova AG
 Vista S7-Dir R 063-6395-01442025-12-29
Sonova AG
 Vista S5-Dir R 063-6394-01442025-12-29
Sonova AG
 AudioNova S7-10 O 063-6400-01652025-12-29
Sonova AG
 AudioNova S5-10 O 063-6399-01652025-12-29
Sonova AG
 AudioNova S3-10 O 063-6398-01652025-12-29
Sonova AG
 AudioNova S1-10 O 063-6397-01652025-12-29
Sonova AG
 Vista S3-Dir R 063-6393-01442025-12-29
Sonova AG
 Vista S1-Dir R 063-6392-01442025-12-29
Sonova AG
 Insera S9-10 NW O 063-6401-012025-12-29
Sonova AG
 Insera S7-10 NW O 063-6400-012025-12-29
Sonova AG
 Insera S5-10 NW O 063-6399-012025-12-29
Sonova AG
 Insera S3-10 NW O 063-6398-012025-12-29
Sonova AG
 Insera S1-10 NW O 063-6397-012025-12-29
Sonova AG
 Insera S9-R 063-6396-012025-12-29
Sonova AG
 Insera S7-R 063-6395-012025-12-29
Sonova AG
 Insera S5-R 063-6394-012025-12-29
Sonova AG
 Insera S3-R 063-6393-012025-12-29
Sonova AG
 Insera S1-R 063-6392-012025-12-29
Sonova AG
 Easy Line Charger ITE 075-5895-122025-12-09
Sonova AG
 Easy Line Charger ITE 075-5895-112025-12-09
Sonova AG
 Unitron Charger ITE 075-5894-102025-12-09
Sonova AG
 Easy Line Charger ITE 075-5895-102025-12-09
Sonova AG
 Unitron Charger ITE 075-5894-112025-12-09
Sonova AG
 Unitron Charger ITE 075-5894-102025-12-09
Sonova AG
 Phonak Terra+ RIC-R 050-1149-P82025-11-26
Sonova AG
 Phonak Terra+ RIC-312 050-1107-P82025-11-26
Sonova AG
 Phonak Terra+ BTE-UP 050-1106-P82025-11-26
Sonova AG
 Phonak Terra+ BTE-SP 050-1105-P82025-11-26
Sonova AG
 Phonak Terra+ BTE-M 050-1104-P82025-11-26
Sonova AG
 Phonak Terra RIC-312 050-1103-P82025-11-26
Sonova AG
 Phonak Terra BTE-UP 050-1102-P82025-11-26
Sonova AG
 Phonak Terra BTE-SP 050-1101-P82025-11-26
Sonova AG
 Phonak Terra BTE-M 050-1100-P82025-11-26
Sonova AG
 Phonak ChargerGo RIC I 075-00552025-11-26
Sonova AG
 Phonak Charger RIC I 075-00542025-11-26
Sonova AG
 Phonak ChargerGo RICSPH I 075-00572025-11-26
Sonova AG
 Easy Line Charger RIC 2 075-58712025-11-26
Sonova AG
 Unitron Charger Moxi R 2 075-58702025-11-26
Sonova AG
 Phonak MiniControl 054-10062025-09-30
Sonova AG
 IIC Remote Control 054-10052025-09-30
Sonova AG
 Phonak Naída L30-M 050-1164-H02025-09-04
Sonova AG
 myPhonak Junior 2.0 088-0017-000202025-09-03
Sonova AG
 Phonak Target 11.1 088-0125-001112025-09-02
Sonova AG
 USB Phonak Target 11.1 USB 058-0325-1112025-09-02
Sonova AG
 DVD Phonak Target 11.1 DVD 058-0125-1112025-09-02
Sonova AG
 MEMINI E D 5P R-R AI PH 050-1030-P6B12025-08-26
Sonova AG
 MEMINI E 4 5P R-R AI PH 050-1060-P8B12025-08-26
Sonova AG
 MEMINI E 4 5P R-R AI PH 050-1060-P6B12025-08-26
Sonova AG
 MEMINI E 4 5P R-R AI PH 050-1060-P3B12025-08-26
Sonova AG
 MEMINI E 4 5P R-R AI PH 050-1060-P1B12025-08-26
Sonova AG
 MEMINI E 5 5P R-R AI PH 050-1029-P8B12025-08-26
Sonova AG
 MEMINI E 5 5P R-R AI PH 050-1029-P6B12025-08-26
Sonova AG
 MEMINI E 5 5P R-R AI PH 050-1029-P3B12025-08-26
Sonova AG
 MEMINI E 5 5P R-R AI PH 050-1029-P1B12025-08-26
Sonova AG
 ampli-mini E D 5P R-R AI PH 050-1030-P6672025-08-26
Sonova AG
 ampli-mini E 4 5P R-R AI PH 050-1060-P8672025-08-26
Sonova AG
 ampli-mini E 4 5P R-R AI PH 050-1060-P6672025-08-26
Sonova AG
 ampli-mini E 4 5P R-R AI PH 050-1060-P3672025-08-26
Sonova AG
 ampli-mini E 4 5P R-R AI PH 050-1060-P1672025-08-26
Sonova AG
 ampli-mini E 5 5P R-R AI PH 050-1029-P8672025-08-26
Sonova AG
 ampli-mini E 5 5P R-R AI PH 050-1029-P6672025-08-26
Sonova AG
 ampli-mini E 5 5P R-R AI PH 050-1029-P3672025-08-26
Sonova AG
 ampli-mini E 5 5P R-R AI PH 050-1029-P1672025-08-26
Sonova AG
 Phonak Charger Virto I 075-0075-030B32025-07-11
Sonova AG
 Phonak Target 11.0 088-0125-001102025-05-28
Sonova AG
 USB Phonak Target 11.0 USB 058-0325-1102025-05-28
Sonova AG
 DVD Phonak Target 11.0 DVD 058-0125-1102025-05-28
Sonova AG
 Sennheiser Sonite R Loaner 050-1133-H0572025-04-11
Sonova AG
 Aura:fit Relate 5.8 058-5267-0582025-04-09
Sonova AG
 Aura:fit AudioNova 5.8 058-5262-0582025-04-09
Sonova AG
 Aura:fit 5.8 058-5180-0582025-04-09
Sonova AG
 Unitron TrueFit 5.8 DVD 058-5178-0582025-04-09
Sonova AG
 Unitron TrueFit 5.8 USB 058-5268-0582025-04-09
Sonova AG
 Unitron TrueFit 5.8 088-5019-000582025-04-09
Sonova AG
 Au V-PR trial 050-6831-P6742025-04-01
Sonova AG
 Au V-M trial 050-6865-P6742025-04-01
Sonova AG
 Au V5-M 050-6862-P6742025-04-01
Sonova AG
 Au V7-M 050-6863-P6742025-04-01
Sonova AG
 Au V9-M 050-6864-P6742025-04-01
Sonova AG
 Au V-312 trial 050-6825-P6742025-04-01
Sonova USA Inc. [Sonova AG]
Phonak Virto V2014-01-06
Sonova USA Inc. [Sonova AG]
Phonak Virto M2014-01-06
Sonova USA Inc. [Sonova AG]
Phonak Naida V2014-01-06
Sonova USA Inc. [Sonova AG]
Phonak Naida M2014-01-06
Sonova USA Inc. [Sonova AG]
Phonak Bolero V2014-01-06
Sonova USA Inc. [Sonova AG]
Phonak Bolero M2014-01-06
Sonova USA Inc. [Sonova AG]
Phonak Bolero B2014-01-06
Sonova USA Inc. [Sonova AG]
Phonak Audeo M2014-01-06
Sonova USA Inc. [Sonova AG]
Phonak Audeo B2014-01-06
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Virto V2014-01-06
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Virto M2014-01-06
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Naida V2014-01-06
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Naida M2014-01-06
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Bolero V2014-01-06
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Bolero M2014-01-06
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Bolero B2014-01-06
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Audeo M2014-01-06
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Audeo B2014-01-06
Mario Castano [Sonova AG]
Phonak Virto V2014-01-06
Mario Castano [Sonova AG]
Phonak Virto V2014-01-06
Mario Castano [Sonova AG]
Phonak Virto M2014-01-06
Mario Castano [Sonova AG]
Phonak Virto M2014-01-06
Mario Castano [Sonova AG]
Phonak Naida V2014-01-06
Mario Castano [Sonova AG]
Phonak Naida V2014-01-06
Mario Castano [Sonova AG]
Phonak Naida M2014-01-06
Mario Castano [Sonova AG]
Phonak Naida M2014-01-06
Mario Castano [Sonova AG]
Phonak Bolero V2014-01-06
Mario Castano [Sonova AG]
Phonak Bolero V2014-01-06
Mario Castano [Sonova AG]
Phonak Bolero M2014-01-06
Mario Castano [Sonova AG]
Phonak Bolero M2014-01-06
Mario Castano [Sonova AG]
Phonak Bolero B2014-01-06
Mario Castano [Sonova AG]
Phonak Bolero B2014-01-06
Mario Castano [Sonova AG]
Phonak Audeo M2014-01-06
Mario Castano [Sonova AG]
Phonak Audeo M2014-01-06
Mario Castano [Sonova AG]
Phonak Audeo B2014-01-06
Mario Castano [Sonova AG]
Phonak Audeo B2014-01-06
Sonova USA Inc. [Sonova AG]
Unitron Vista2011-08-09
Sonova USA Inc. [Sonova AG]
Unitron Stride2011-08-09
Sonova USA Inc. [Sonova AG]
Unitron Stride P2011-08-09
Sonova USA Inc. [Sonova AG]
Unitron Stride P Dura2011-08-09
Sonova USA Inc. [Sonova AG]
Unitron Remote Plus2011-08-09
Sonova USA Inc. [Sonova AG]
PilotOne II2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Virto V2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Virto M2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Virto B2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Sky V2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Sky M2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Sky B2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Naida V2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Naida M2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Naida Link2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Naida Link CROS2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Naida B2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak CROS B2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Brio 42011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Brio 32011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Bolero V2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Bolero M2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Bolero B2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Audeo M2011-08-09
Sonova USA Inc. [Sonova AG]
Phonak Audeo B2011-08-09
Sonova USA Inc. [Sonova AG]
Naida CI Connect2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Unitron Vista2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Unitron Stride2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Unitron Stride P2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Unitron Stride P Dura2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Unitron Remote Plus2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
PilotOne II2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Virto V2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Virto M2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Virto B2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Sky V2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Sky M2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Sky B2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Naida V2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Naida M2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Naida Link2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Naida Link CROS2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Naida B2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak CROS B2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Brio 42011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Brio 32011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Bolero V2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Bolero M2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Bolero B2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Audeo M2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Audeo B2011-08-09
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Naida CI Connect2011-08-09
Mario Castano [Sonova AG]
Unitron Vista2011-08-09
Mario Castano [Sonova AG]
Unitron Vista2011-08-09
Mario Castano [Sonova AG]
Unitron Stride2011-08-09
Mario Castano [Sonova AG]
Unitron Stride2011-08-09
Mario Castano [Sonova AG]
Unitron Stride P2011-08-09
Mario Castano [Sonova AG]
Unitron Stride P2011-08-09
Mario Castano [Sonova AG]
Unitron Stride P Dura2011-08-09
Mario Castano [Sonova AG]
Unitron Stride P Dura2011-08-09
Mario Castano [Sonova AG]
Unitron Remote Plus2011-08-09
Mario Castano [Sonova AG]
Unitron Remote Plus2011-08-09
Mario Castano [Sonova AG]
PilotOne II2011-08-09
Mario Castano [Sonova AG]
PilotOne II2011-08-09
Mario Castano [Sonova AG]
Phonak Virto V2011-08-09
Mario Castano [Sonova AG]
Phonak Virto V2011-08-09
Mario Castano [Sonova AG]
Phonak Virto M2011-08-09
Mario Castano [Sonova AG]
Phonak Virto M2011-08-09
Mario Castano [Sonova AG]
Phonak Virto B2011-08-09
Mario Castano [Sonova AG]
Phonak Virto B2011-08-09
Mario Castano [Sonova AG]
Phonak Sky V2011-08-09
Mario Castano [Sonova AG]
Phonak Sky V2011-08-09
Mario Castano [Sonova AG]
Phonak Sky M2011-08-09
Mario Castano [Sonova AG]
Phonak Sky M2011-08-09
Mario Castano [Sonova AG]
Phonak Sky B2011-08-09
Mario Castano [Sonova AG]
Phonak Sky B2011-08-09
Mario Castano [Sonova AG]
Phonak Naida V2011-08-09
Mario Castano [Sonova AG]
Phonak Naida V2011-08-09
Mario Castano [Sonova AG]
Phonak Naida M2011-08-09
Mario Castano [Sonova AG]
Phonak Naida M2011-08-09
Mario Castano [Sonova AG]
Phonak Naida Link2011-08-09
Mario Castano [Sonova AG]
Phonak Naida Link2011-08-09
Mario Castano [Sonova AG]
Phonak Naida Link CROS2011-08-09
Mario Castano [Sonova AG]
Phonak Naida Link CROS2011-08-09
Mario Castano [Sonova AG]
Phonak Naida B2011-08-09
Mario Castano [Sonova AG]
Phonak Naida B2011-08-09
Mario Castano [Sonova AG]
Phonak CROS B2011-08-09
Mario Castano [Sonova AG]
Phonak CROS B2011-08-09
Mario Castano [Sonova AG]
Phonak Brio 42011-08-09
Mario Castano [Sonova AG]
Phonak Brio 42011-08-09
Mario Castano [Sonova AG]
Phonak Brio 32011-08-09
Mario Castano [Sonova AG]
Phonak Brio 32011-08-09
Mario Castano [Sonova AG]
Phonak Bolero V2011-08-09
Mario Castano [Sonova AG]
Phonak Bolero V2011-08-09
Mario Castano [Sonova AG]
Phonak Bolero M2011-08-09
Mario Castano [Sonova AG]
Phonak Bolero M2011-08-09
Mario Castano [Sonova AG]
Phonak Bolero B2011-08-09
Mario Castano [Sonova AG]
Phonak Bolero B2011-08-09
Mario Castano [Sonova AG]
Phonak Audeo M2011-08-09
Mario Castano [Sonova AG]
Phonak Audeo M2011-08-09
Mario Castano [Sonova AG]
Phonak Audeo B2011-08-09
Mario Castano [Sonova AG]
Phonak Audeo B2011-08-09
Mario Castano [Sonova AG]
Naida CI Connect2011-08-09
Mario Castano [Sonova AG]
Naida CI Connect2011-08-09
Sonova USA Inc. [Sonova AG]
Virto M2006-09-14
Sonova USA Inc. [Sonova AG]
Unitron Vista2006-09-14
Sonova USA Inc. [Sonova AG]
Unitron Shine Rev2006-09-14
Sonova USA Inc. [Sonova AG]
Phonak Virto V2006-09-14
Sonova USA Inc. [Sonova AG]
Phonak Virto B2006-09-14
Sonova USA Inc. [Sonova AG]
Phonak Brio 32006-09-14
Sonova USA Inc. [Sonova AG]
Lyric32006-09-14
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Virto M2006-09-14
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Unitron Vista2006-09-14
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Unitron Shine Rev2006-09-14
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Virto V2006-09-14
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Virto B2006-09-14
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Phonak Brio 32006-09-14
Sonova Operations Center Vietnam Co., Ltd [Sonova AG]
Lyric32006-09-14
Mario Castano [Sonova AG]
Virto M2006-09-14
Mario Castano [Sonova AG]
Virto M2006-09-14
Mario Castano [Sonova AG]
Unitron Vista2006-09-14
Mario Castano [Sonova AG]
Unitron Vista2006-09-14
Mario Castano [Sonova AG]
Unitron Shine Rev2006-09-14
Mario Castano [Sonova AG]
Unitron Shine Rev2006-09-14
Mario Castano [Sonova AG]
Phonak Virto V2006-09-14
Mario Castano [Sonova AG]
Phonak Virto V2006-09-14
Mario Castano [Sonova AG]
Phonak Virto B2006-09-14
Mario Castano [Sonova AG]
Phonak Virto B2006-09-14
Mario Castano [Sonova AG]
Phonak Brio 32006-09-14
Mario Castano [Sonova AG]
Phonak Brio 32006-09-14
Mario Castano [Sonova AG]
Lyric32006-09-14
Mario Castano [Sonova AG]
Lyric32006-09-14

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