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.
| Registration Number | 1221770 |
| FEI Number | 1221770 |
| Name | SIGVARIS, INC. |
| Owner & Operator | GANZONI & CIE AG |
| Contact Address | GROEBLISTRASSE 8 -- ST GALLEN CH-NOTA 9014 CH |
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 1119 Highway 74 S PEACHTREE CITY, GA 30269 US |
| Establishment Type | Repack or Relabel Medical Device |
Device Company | Device | Date |
|---|---|---|
| SIGVARIS INC | Cflex Reduce Full Leg LG LG LG Reg Right Beige 241333-THR-R | 2025-08-25 |
| SIGVARIS INC | Cflex Reduce Full Leg LG LG LG Reg Right Black 240333-THR-R | 2025-08-25 |
| SIGVARIS INC | Cflex Reduce Full Leg SM SM SM Reg Right Beige 241111-THR-R | 2025-08-25 |
| SIGVARIS INC | Cflex Reduce Full Leg SM SM SM Reg Right Black 240111-THR-R | 2025-08-25 |
| SIGVARIS INC | Cflex Reduce Full Leg LG LG LG Tall Right Beige 241333-THT-R | 2025-08-25 |
| SIGVARIS INC | Cflex Reduce Full Leg LG LG LG Tall Right Black 240333-THT-R | 2025-08-25 |
| SIGVARIS INC | Cflex Reduce Full Leg SM SM SM Tall Right Beige 241111-THT-R | 2025-08-25 |
| SIGVARIS INC | Cflex Reduce Full Leg SM SM SM Tall Right Black 240111-THT-R | 2025-08-25 |
| SIGVARIS INC | Cflex Reduce Full Leg LG LG LG Reg Left Beige 241333-THR-L | 2025-08-25 |
| SIGVARIS INC | Cflex Reduce Full Leg LG LG LG Reg Left Black 240333-THR-L | 2025-08-25 |
| SIGVARIS INC | Cflex Reduce Full Leg SM SM SM Reg Left Beige 241111-THR-L | 2025-08-25 |
| SIGVARIS INC | Cflex Reduce Full Leg SM SM SM Reg Left Black 240111-THR-L | 2025-08-25 |
| SIGVARIS INC | Cflex Reduce Full Leg LG LG LG Tall Left Beige 241333-THT-L | 2025-08-25 |
| SIGVARIS INC | Cflex Reduce Full Leg LG LG LG Tall Left Black 240333-THT-L | 2025-08-25 |
| SIGVARIS INC | Cflex Reduce Full Leg SM SM SM Tall Left Beige 241111-THT-L | 2025-08-25 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U ML White 442CML00 | 2025-08-25 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U LS White 442CLS00 | 2025-08-25 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U LM White 442CLM00 | 2025-08-25 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U LL White 442CLL00 | 2025-08-19 |
| SIGVARIS INC | Coolflex Boot XL/XXL Reg RT Black (BULK) 2105-BTR-R | 2025-08-19 |
| SIGVARIS INC | Coolflex Boot XL/XXL Reg LT Black (BULK) 2105-BTR-L | 2025-08-19 |
| SIGVARIS INC | Coolflex Boot XL/XXL Long RT Black (BULK) 2105-BTL-R | 2025-08-19 |
| SIGVARIS INC | Coolflex Boot XL/XXL Long LT Black (BULK) 2105-BTL-L | 2025-08-19 |
| SIGVARIS INC | Coolflex Boot M/L Reg RT Black (BULK) 2103-BTR-R | 2025-08-19 |
| SIGVARIS INC | Coolflex Boot M/L Reg LT Black (BULK) 2103-BTR-L | 2025-08-19 |
| SIGVARIS INC | Coolflex Boot M/L Long RT Black (BULK) 2103-BTL-R | 2025-08-19 |
| SIGVARIS INC | Coolflex Boot M/L Long LT Black (BULK) 2103-BTL-L | 2025-08-19 |
| SIGVARIS INC | Coolflex Boot SM Reg RT Black (BULK) 2101-BTR-R | 2025-08-19 |
| SIGVARIS INC | Coolflex Boot SM Reg LT Black (BULK) 2101-BTR-L | 2025-08-19 |
| SIGVARIS INC | Coolflex Boot SM Long RT Black (BULK) 2101-BTL-R | 2025-08-19 |
| SIGVARIS INC | Coolflex Arm X Large Short Right (BULK) 2104-ARS-R | 2025-08-19 |
| SIGVARIS INC | Coolflex Arm X Large Short Left (BULK) 2104-ARS-L | 2025-08-19 |
| SIGVARIS INC | Coolflex Arm X Large Regular Right (BULK) 2104-ARR-R | 2025-08-19 |
| SIGVARIS INC | Coolflex Arm X Large Regular Left (BULK) 2104-ARR-L | 2025-08-19 |
| SIGVARIS INC | Coolflex Arm X Large Long Right (BULK) 2104-ARL-R | 2025-08-19 |
| SIGVARIS INC | Coolflex Arm X Large Long Left (BULK) 2104-ARL-L | 2025-08-19 |
| SIGVARIS INC | Coolflex Arm Large Short Right (BULK) 2103-ARS-R | 2025-08-19 |
| SIGVARIS INC | Coolflex Arm Large Short Left (BULK) 2103-ARS-L | 2025-08-19 |
| SIGVARIS INC | Coolflex Arm Large Regular Right (BULK) 2103-ARR-R | 2025-08-19 |
| SIGVARIS INC | Coolflex Arm Large Regular Left (BULK) 2103-ARR-L | 2025-08-19 |
| SIGVARIS INC | Coolflex Arm Large Long Right (BULK) 2103-ARL-R | 2025-08-19 |
| SIGVARIS INC | Coolflex Arm Large Long Left (BULK) 2103-ARL-L | 2025-08-19 |
| SIGVARIS INC | Coolflex Arm Medium Short Right (BULK) 2102-ARS-R | 2025-08-19 |
| SIGVARIS INC | Coolflex Arm Medium Short Left (BULK) 2102-ARS-L | 2025-08-19 |
| SIGVARIS INC | Coolflex Arm Medium Regular Right (BULK) 2102-ARR-R | 2025-08-19 |
| SIGVARIS INC | Coolflex Arm Medium Regular Left (BULK) 2102-ARR-L | 2025-08-19 |
| SIGVARIS INC | Coolflex Arm Medium Long Right (BULK) 2102-ARL-R | 2025-08-19 |
| SIGVARIS INC | Coolflex Arm Medium Long Left (BULK) 2102-ARL-L | 2025-08-19 |
| SIGVARIS INC | Coolflex Arm Small Short Right (BULK) 2101-ARS-R | 2025-08-19 |
| SIGVARIS INC | Coolflex Arm Small Short Left (BULK) 2101-ARS-L | 2025-08-19 |
| SIGVARIS INC | Coolflex Arm Small Regular Right (BULK) 2101-ARR-R | 2025-08-19 |
| SIGVARIS INC | Coolflex Arm Small Regular Left (BULK) 2101-ARR-L | 2025-08-19 |
| SIGVARIS INC | Textile Donning Gloves 593RPRXL | 2025-07-24 |
| SIGVARIS INC | Textile Donning Gloves 593RPRL | 2025-07-24 |
| SIGVARIS INC | Textile Donning Gloves 593RPRM | 2025-07-24 |
| SIGVARIS INC | Textile Donning Gloves 593RPRS | 2025-07-24 |
| SIGVARIS INC | Textile Donning Gloves 593RPRXS | 2025-07-24 |
| SIGVARIS INC | Cflex Reduce Full Leg SM SM SM Tall Left Black 240111-THT-L | 2025-07-24 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD SensinovaUnisex UNI °° marine 355556 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD QuadrinovaSlim UNI °° marine 355555 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD SensinovaUnisex UNI marine 355517 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD QuadrinovaSlim UNI marine 355516 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD Quadrinova UNI marine 355515 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD Quadrinova UNI Skin 320242 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD QuadrinovaSlim UNI Skin 320243 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD SensinovaUnisex UNI Skin 320244 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD QuadrinovaSlim UNI °° Skin 320282 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD SensinovaUnisex UNI °° Skin 320283 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD Quadrinova UNI Savanna 320320 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD QuadrinovaSlim UNI Savanna 320321 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD SensinovaUnisex UNI Savanna 320322 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD QuadrinovaSlim UNI °° Savanna 320360 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD SensinovaUnisex UNI °° Savanna 320361 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD Quadrinova UNI Grey 320398 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD QuadrinovaSlim UNI Grey 320399 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD SensinovaUnisex UNI Grey 320400 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD QuadrinovaSlim UNI °° Grey 320438 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD SensinovaUnisex UNI °° Grey 320439 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD Quadrinova UNI Caramel 320476 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD QuadrinovaSlim UNI Caramel 320477 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD SensinovaUnisex UNI Caramel 320478 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD QuadrinovaSlim UNI °° Caramel 320516 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD SensinovaUnisex UNI °° Caramel 320517 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD Quadrinova UNI Black 320554 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD QuadrinovaSlim UNI Black 320555 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD SensinovaUnisex UNI Black 320556 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD QuadrinovaSlim UNI °° Black 320594 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD SensinovaUnisex UNI °° Black 320595 | 2025-07-21 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD SoftTop UNI °° Black 320596 | 2025-07-21 |
| SIGVARIS INC | Compreflex Pulse Calf SM R Beige 3611-UC-BKR | 2025-07-11 |
| SIGVARIS INC | Compreflex Pulse Calf XL T Black 3604-UC-BKT | 2025-07-11 |
| SIGVARIS INC | Compreflex Pulse Calf XL R Black 3604-UC-BKR | 2025-07-11 |
| SIGVARIS INC | Compreflex Pulse Calf LG T Black 3603-UC-BKT | 2025-07-11 |
| SIGVARIS INC | Compreflex Pulse Calf LG R Black 3603-UC-BKR | 2025-07-11 |
| SIGVARIS INC | Compreflex Pulse Calf MD T Black 3602-UC-BKT | 2025-07-11 |
| SIGVARIS INC | Compreflex Pulse Calf MD R Black 3602-UC-BKR | 2025-07-11 |
| SIGVARIS INC | Compreflex Pulse Calf SM T Black 3601-UC-BKT | 2025-07-11 |
| SIGVARIS INC | Coolflex Boot SM Long LT Black (BULK) 2101-BTL-L | 2025-07-11 |
| SIGVARIS INC | Coolflex Arm Small Long Right (BULK) 2101-ARL-R | 2025-07-11 |
| SIGVARIS INC | Coolflex Arm Small Long Left (BULK) 2101-ARL-L | 2025-07-11 |
SIGVARIS, INC. [GANZONI & CIE AG] | SIGVARIS | 2007-01-04 |
SIGVARIS, INC. [GANZONI & CIE AG] | Transition Liner | 2001-11-05 |
SIGVARIS, INC. [GANZONI & CIE AG] | SIGVARIS | 2001-11-05 |
SIGVARIS, INC. [GANZONI & CIE AG] | Complete Liner | 2001-11-05 |
SIGVARIS, INC. [GANZONI & CIE AG] | Basic Liner | 2001-11-05 |
| NCAGE Code | 09BU5 | SIGVARIS INC |
| CAGE Code | 09BU5 | SIGVARIS INC |
| CAGE Code | 46HS7 | SIGVARIS INC SIGVARIS |
| S.A.M. Registration | 46HS7 [189738719] | SIGVARIS INC |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020092842601 | Rotterdam,Netherlands -> Savannah, Georgia | 20 PALLETS (= 20 CARDBOARD- CONTAINER) BANDAGE MATERIAL HS CODE NOS. 3005-9050 CONSIGNEE | 20 PKG |
| 202009022420 | Le Havre,France -> New York/Newark Area, Newark, New Jersey | OPALIS TOP BAND LOADED ON 2 PALLETS HS-CODE 59039099 | 41 PCS |
| 2020082558149 | Bremerhaven,Federal Republic of Germany -> Savannah, Georgia | ELASTIC STUFFED ON 5 PALLETS HS. 580390 HBL BANQBRE4407566 NOT STACKABLE | 69 CTN |
| 2020082557958 | Anvers,Belgium -> Charleston, South Carolina | BANDAGE MATERIAL HS CODE 30059050 | 7 PKG |
| 2020082462439 | Bremerhaven,Federal Republic of Germany -> Savannah, Georgia | ELASTIC STUFFED ON 5 PALLETS HS. 580390 HBL BANQBRE4407566 NOT STACKABLE | 69 CTN |
| 2020082281908 | Anvers,Belgium -> Charleston, South Carolina | BANDAGE MATERIAL HS CODE 30059050 | 7 PKG |
| 2020070355492 | Le Havre,France -> New York/Newark Area, Newark, New Jersey | OPALIS TOP BAND LOADED ON 2 PALLETS HS-CODE 59039099 | 41 PCS |
| 2020062075629 | Le Havre,France -> New York/Newark Area, Newark, New Jersey | OPALIS TOP BAND LOADED ON 2 PALLETS HS-CODE 59039099 | 41 PCS |