Sigvaris Inc

FDA Filings

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

FDA Registration(s)
Registration Number1221770
FEI Number1221770
NameSIGVARIS, INC.
Owner & OperatorGANZONI & CIE AG
Contact AddressGROEBLISTRASSE 8 --
ST GALLEN CH-NOTA 9014 CH
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address1119 Highway 74 S
PEACHTREE CITY, GA 30269 US
Establishment TypeRepack or Relabel Medical Device



FDA Filings

Device
Company
DeviceDate
SIGVARIS INC
Textile Donning Gloves 593RPRXL2025-07-24
SIGVARIS INC
Textile Donning Gloves 593RPRL2025-07-24
SIGVARIS INC
Textile Donning Gloves 593RPRM2025-07-24
SIGVARIS INC
Textile Donning Gloves 593RPRS2025-07-24
SIGVARIS INC
Textile Donning Gloves 593RPRXS2025-07-24
SIGVARIS INC
Cflex Reduce Full Leg SM SM SM Tall Left Black 240111-THT-L2025-07-24
SIGVARIS INC
862C-CUSTOM ECF2 AD SensinovaUnisex UNI °° marine 3555562025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD QuadrinovaSlim UNI °° marine 3555552025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD SensinovaUnisex UNI marine 3555172025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD QuadrinovaSlim UNI marine 3555162025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD Quadrinova UNI marine 3555152025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD Quadrinova UNI Skin 3202422025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD QuadrinovaSlim UNI Skin 3202432025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD SensinovaUnisex UNI Skin 3202442025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD QuadrinovaSlim UNI °° Skin 3202822025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD SensinovaUnisex UNI °° Skin 3202832025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD Quadrinova UNI Savanna 3203202025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD QuadrinovaSlim UNI Savanna 3203212025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD SensinovaUnisex UNI Savanna 3203222025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD QuadrinovaSlim UNI °° Savanna 3203602025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD SensinovaUnisex UNI °° Savanna 3203612025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD Quadrinova UNI Grey 3203982025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD QuadrinovaSlim UNI Grey 3203992025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD SensinovaUnisex UNI Grey 3204002025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD QuadrinovaSlim UNI °° Grey 3204382025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD SensinovaUnisex UNI °° Grey 3204392025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD Quadrinova UNI Caramel 3204762025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD QuadrinovaSlim UNI Caramel 3204772025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD SensinovaUnisex UNI Caramel 3204782025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD QuadrinovaSlim UNI °° Caramel 3205162025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD SensinovaUnisex UNI °° Caramel 3205172025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD Quadrinova UNI Black 3205542025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD QuadrinovaSlim UNI Black 3205552025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD SensinovaUnisex UNI Black 3205562025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD QuadrinovaSlim UNI °° Black 3205942025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD SensinovaUnisex UNI °° Black 3205952025-07-21
SIGVARIS INC
862C-CUSTOM ECF2 AD SoftTop UNI °° Black 3205962025-07-21
SIGVARIS INC
Compreflex Pulse Calf XL T Beige 3614-UC-BKT2025-07-11
SIGVARIS INC
Compreflex Pulse Calf XL R Beige 3614-UC-BKR2025-07-11
SIGVARIS INC
Compreflex Pulse Calf LG T Beige 3613-UC-BKT2025-07-11
SIGVARIS INC
Compreflex Pulse Calf LG R Beige 3613-UC-BKR2025-07-11
SIGVARIS INC
Compreflex Pulse Calf MD T Beige 3612-UC-BKT2025-07-11
SIGVARIS INC
Compreflex Pulse Calf MD R Beige 3612-UC-BKR2025-07-11
SIGVARIS INC
Compreflex Pulse Calf SM T Beige 3611-UC-BKT2025-07-11
SIGVARIS INC
Compreflex Pulse Calf SM R Beige 3611-UC-BKR2025-07-11
SIGVARIS INC
Compreflex Pulse Calf XL T Black 3604-UC-BKT2025-07-11
SIGVARIS INC
Compreflex Pulse Calf XL R Black 3604-UC-BKR2025-07-11
SIGVARIS INC
Compreflex Pulse Calf LG T Black 3603-UC-BKT2025-07-11
SIGVARIS INC
Compreflex Pulse Calf LG R Black 3603-UC-BKR2025-07-11
SIGVARIS INC
Compreflex Pulse Calf MD T Black 3602-UC-BKT2025-07-11
SIGVARIS INC
Compreflex Pulse Calf MD R Black 3602-UC-BKR2025-07-11
SIGVARIS INC
Compreflex Pulse Calf SM T Black 3601-UC-BKT2025-07-11
SIGVARIS INC
Coolflex Boot SM Long LT Black (BULK) 2101-BTL-L2025-07-11
SIGVARIS INC
Coolflex Arm Small Long Right (BULK) 2101-ARL-R2025-07-11
SIGVARIS INC
Coolflex Arm Small Long Left (BULK) 2101-ARL-L2025-07-11
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 N M Black ETH1D2231992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 L M Black ETH1D2331992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 N L Black ETH1D3231992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 L L Black ETH1D3331992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 N XS Plus Black ETH1DP0231992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 L XS Plus Black ETH1DP0331992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 N S Plus Black ETH1DP1231992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 L S Plus Black ETH1DP1331992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 N M Plus Black ETH1DP2231992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 L M Plus Black ETH1DP2331992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 N L Plus Black ETH1DP3231992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 L L Plus Black ETH1DP3331992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 N XS Nature ETH1D0231762025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 L XS Nature ETH1D0331762025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 N S Nature ETH1D1231762025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 L S Nature ETH1D1331762025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 N M Nature ETH1D2231762025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 L M Nature ETH1D2331762025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 N L Nature ETH1D3231762025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 L L Nature ETH1D3331762025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 N XS Plus Nature ETH1DP0231762025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 L XS Plus Nature ETH1DP0331762025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 N S Plus Nature ETH1DP1231762025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 L S Plus Nature ETH1DP1331762025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 N M Plus Nature ETH1DP2231762025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 L M Plus Nature ETH1DP2331762025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 N L Plus Nature ETH1DP3231762025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 L L Plus Nature ETH1DP3331762025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 L L Plus Black ETH1DP331992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 N L Plus Black ETH1DP321992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 L M Plus Black ETH1DP231992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 N M Plus Black ETH1DP221992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 L S Plus Black ETH1DP131992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 N S Plus Black ETH1DP121992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 L XS Plus Black ETH1DP031992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 N XS Plus Black ETH1DP021992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 L L Black ETH1D331992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 N L Black ETH1D321992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 L M Black ETH1D231992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 N M Black ETH1D221992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 L S Black ETH1D121992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 N S Black ETH1D121992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 L XS Black ETH1D031992025-07-10
SIGVARIS INC
ETH1 Calf Essential Thermo CCL1 N XS Black ETH1D021992025-07-10
SIGVARIS INC
Compreflex Pulse Calf SM R Black 3601-UC-BKR2025-07-10
SIGVARIS, INC. [GANZONI & CIE AG]
SIGVARIS2007-01-04
SIGVARIS, INC. [GANZONI & CIE AG]
Transition Liner2001-11-05
SIGVARIS, INC. [GANZONI & CIE AG]
SIGVARIS2001-11-05
SIGVARIS, INC. [GANZONI & CIE AG]
Complete Liner2001-11-05
SIGVARIS, INC. [GANZONI & CIE AG]
Basic Liner2001-11-05

Related Finance Registrations
NCAGE Code09BU5SIGVARIS INC
CAGE Code09BU5SIGVARIS INC
CAGE Code46HS7SIGVARIS INC SIGVARIS
S.A.M. Registration46HS7 [189738719]SIGVARIS INC
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092842601Rotterdam,Netherlands -> Savannah, Georgia20 PALLETS (= 20 CARDBOARD- CONTAINER) BANDAGE MATERIAL HS CODE NOS. 3005-9050 CONSIGNEE20 PKG
202009022420Le Havre,France -> New York/Newark Area, Newark, New JerseyOPALIS TOP BAND LOADED ON 2 PALLETS HS-CODE 5903909941 PCS
2020082558149Bremerhaven,Federal Republic of Germany -> Savannah, GeorgiaELASTIC STUFFED ON 5 PALLETS HS. 580390 HBL BANQBRE4407566 NOT STACKABLE69 CTN
2020082557958Anvers,Belgium -> Charleston, South CarolinaBANDAGE MATERIAL HS CODE 300590507 PKG
2020082462439Bremerhaven,Federal Republic of Germany -> Savannah, GeorgiaELASTIC STUFFED ON 5 PALLETS HS. 580390 HBL BANQBRE4407566 NOT STACKABLE69 CTN
2020082281908Anvers,Belgium -> Charleston, South CarolinaBANDAGE MATERIAL HS CODE 300590507 PKG
2020070355492Le Havre,France -> New York/Newark Area, Newark, New JerseyOPALIS TOP BAND LOADED ON 2 PALLETS HS-CODE 5903909941 PCS
2020062075629Le Havre,France -> New York/Newark Area, Newark, New JerseyOPALIS TOP BAND LOADED ON 2 PALLETS HS-CODE 5903909941 PCS

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