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 | 861P-CUSTOM ECF1 AT SoftTop MEN °° marine 355545 | 2025-04-07 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT SoftTop FEM °° marine 355544 | 2025-04-07 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT SoftTop MEN marine 355509 | 2025-04-07 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT SoftTop FEM marine 355508 | 2025-04-07 |
| SIGVARIS INC | 861W-CUSTOM ECF1 AGT WaistAttachment UNI marine 355507 | 2025-04-07 |
| SIGVARIS INC | 861W-CUSTOM ECF1 AGT WaistAttachment UNI Skin 320234 | 2025-04-07 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT SoftTop FEM Skin 320235 | 2025-04-07 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT SoftTop MEN Skin 320236 | 2025-04-07 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT SoftTop FEM °° Skin 320271 | 2025-04-07 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT SoftTop MEN °° Skin 320272 | 2025-04-07 |
| SIGVARIS INC | 861W-CUSTOM ECF1 AGT WaistAttachment UNI Savanna 320312 | 2025-04-07 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT SoftTop FEM Savanna 320313 | 2025-04-07 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT SoftTop MEN Savanna 320314 | 2025-04-07 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT SoftTop FEM °° Savanna 320349 | 2025-04-07 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT SoftTop MEN °° Savanna 320350 | 2025-04-07 |
| SIGVARIS INC | 861W-CUSTOM ECF1 AGT WaistAttachment UNI Grey 320390 | 2025-04-07 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT SoftTop FEM Grey 320391 | 2025-04-07 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT SoftTop MEN Grey 320392 | 2025-04-07 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT SoftTop FEM °° Grey 320427 | 2025-04-07 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT SoftTop MEN °° Grey 320428 | 2025-04-07 |
| SIGVARIS INC | 861W-CUSTOM ECF1 AGT WaistAttachment UNI Caramel 320468 | 2025-04-07 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT SoftTop FEM Caramel 320469 | 2025-04-07 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT SoftTop MEN Caramel 320470 | 2025-04-07 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT SoftTop FEM °° Caramel 320505 | 2025-04-07 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT SoftTop MEN °° Caramel 320506 | 2025-04-07 |
| SIGVARIS INC | 861W-CUSTOM ECF1 AGT WaistAttachment UNI Black 320546 | 2025-04-07 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT SoftTop FEM Black 320547 | 2025-04-07 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT SoftTop MEN Black 320548 | 2025-04-07 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT SoftTop FEM °° Black 320583 | 2025-04-07 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT SoftTop MEN °° Black 320584 | 2025-04-07 |
| SIGVARIS INC | 861W-CUSTOM ECF1 AGT WaistAttachment UNI °° marine 355543 | 2025-04-03 |
| SIGVARIS INC | 861T-CUSTOM ECF1 AG SoftTop UNI marine 355506 | 2025-04-03 |
| SIGVARIS INC | 861T-CUSTOM ECF1 AG SoftTop UNI Skin 320233 | 2025-04-03 |
| SIGVARIS INC | 861W-CUSTOM ECF1 AGT WaistAttachment UNI °° Skin 320270 | 2025-04-03 |
| SIGVARIS INC | 861T-CUSTOM ECF1 AG SoftTop UNI Savanna 320311 | 2025-04-03 |
| SIGVARIS INC | 861W-CUSTOM ECF1 AGT WaistAttachment UNI °° Savanna 320348 | 2025-04-03 |
| SIGVARIS INC | 861T-CUSTOM ECF1 AG SoftTop UNI Grey 320389 | 2025-04-03 |
| SIGVARIS INC | 861W-CUSTOM ECF1 AGT WaistAttachment UNI °° Grey 320426 | 2025-04-03 |
| SIGVARIS INC | 861T-CUSTOM ECF1 AG SoftTop UNI Caramel 320467 | 2025-04-03 |
| SIGVARIS INC | 861W-CUSTOM ECF1 AGT WaistAttachment UNI °° Caramel 320504 | 2025-04-03 |
| SIGVARIS INC | 861T-CUSTOM ECF1 AG SoftTop UNI Black 320545 | 2025-04-03 |
| SIGVARIS INC | 861W-CUSTOM ECF1 AGT WaistAttachment UNI °° Black 320582 | 2025-04-03 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AF SensinovaUnisex UNI marine 355502 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG Micro knobbed band UNI Marine 355455 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG Micro knobbed band UNI Black 355454 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG Micro knobbed band UNI Savanna 355453 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG Micro knobbed band UNI Skin 355452 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG Micro knobbed band UNI Caramel 355451 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG Micro knobbed band UNI Grey 355450 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG Micro knobbed band UNI °° Marine 355449 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG Micro knobbed band UNI °° Black 355448 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG Micro knobbed band UNI °° Savanna 355447 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG Micro knobbed band UNI °° Skin 355446 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG Micro knobbed band UNI °° Caramel 355445 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG Micro knobbed band UNI °° Grey 355444 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AF SensinovaUnisex UNI Skin 320229 | 2025-03-31 |
| SIGVARIS INC | 861T-CUSTOM ECF1 AF SoftTop UNI Skin 320230 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG Quadrinova UNI Skin 320231 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG SensinovaUnisex UNI Skin 320232 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AF SensinovaUnisex UNI °° Skin 320265 | 2025-03-31 |
| SIGVARIS INC | 861T-CUSTOM ECF1 AF SoftTop UNI °° Skin 320266 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG Quadrinova UNI °° Skin 320267 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG SensinovaUnisex UNI °° Skin 320268 | 2025-03-31 |
| SIGVARIS INC | 861T-CUSTOM ECF1 AG SoftTop UNI °° Skin 320269 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AF SensinovaUnisex UNI Savanna 320307 | 2025-03-31 |
| SIGVARIS INC | 861T-CUSTOM ECF1 AF SoftTop UNI Savanna 320308 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG Quadrinova UNI Savanna 320309 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG SensinovaUnisex UNI Savanna 320310 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AF SensinovaUnisex UNI °° Savanna 320343 | 2025-03-31 |
| SIGVARIS INC | 861T-CUSTOM ECF1 AF SoftTop UNI °° Savanna 320344 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG Quadrinova UNI °° Savanna 320345 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG SensinovaUnisex UNI °° Savanna 320346 | 2025-03-31 |
| SIGVARIS INC | 861T-CUSTOM ECF1 AG SoftTop UNI °° Savanna 320347 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AF SensinovaUnisex UNI Grey 320385 | 2025-03-31 |
| SIGVARIS INC | 861T-CUSTOM ECF1 AF SoftTop UNI Grey 320386 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG Quadrinova UNI Grey 320387 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG SensinovaUnisex UNI Grey 320388 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AF SensinovaUnisex UNI °° Grey 320421 | 2025-03-31 |
| SIGVARIS INC | 861T-CUSTOM ECF1 AF SoftTop UNI °° Grey 320422 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG Quadrinova UNI °° Grey 320423 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG SensinovaUnisex UNI °° Grey 320424 | 2025-03-31 |
| SIGVARIS INC | 861T-CUSTOM ECF1 AG SoftTop UNI °° Grey 320425 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AF SensinovaUnisex UNI Caramel 320463 | 2025-03-31 |
| SIGVARIS INC | 861T-CUSTOM ECF1 AF SoftTop UNI Caramel 320464 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG Quadrinova UNI Caramel 320465 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG SensinovaUnisex UNI Caramel 320466 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AF SensinovaUnisex UNI °° Caramel 320499 | 2025-03-31 |
| SIGVARIS INC | 861T-CUSTOM ECF1 AF SoftTop UNI °° Caramel 320500 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG Quadrinova UNI °° Caramel 320501 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG SensinovaUnisex UNI °° Caramel 320502 | 2025-03-31 |
| SIGVARIS INC | 861T-CUSTOM ECF1 AG SoftTop UNI °° Caramel 320503 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AF SensinovaUnisex UNI Black 320541 | 2025-03-31 |
| SIGVARIS INC | 861T-CUSTOM ECF1 AF SoftTop UNI Black 320542 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG Quadrinova UNI Black 320543 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG SensinovaUnisex UNI Black 320544 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AF SensinovaUnisex UNI °° Black 320577 | 2025-03-31 |
| SIGVARIS INC | 861T-CUSTOM ECF1 AF SoftTop UNI °° Black 320578 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG Quadrinova UNI °° Black 320579 | 2025-03-31 |
| SIGVARIS INC | 861N-CUSTOM ECF1 AG SensinovaUnisex UNI °° Black 320580 | 2025-03-31 |
| SIGVARIS INC | 861T-CUSTOM ECF1 AG SoftTop UNI °° Black 320581 | 2025-03-31 |
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 |