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 ATM Waistband FEM °° marine 355550 | 2025-06-16 |
| SIGVARIS INC | 861P-CUSTOM ECF1 ATM Waistband FEM marine 355514 | 2025-06-16 |
| SIGVARIS INC | 861P-CUSTOM ECF1 ATB Bodypart MEN with slit Skin 320240 | 2025-06-16 |
| SIGVARIS INC | 861P-CUSTOM ECF1 ATM Waistband FEM Skin 320241 | 2025-06-16 |
| SIGVARIS INC | 861P-CUSTOM ECF1 ATM Waistband FEM °° Skin 320277 | 2025-06-16 |
| SIGVARIS INC | 861P-CUSTOM ECF1 ATB Bodypart MEN with slit Savanna 320318 | 2025-06-16 |
| SIGVARIS INC | 861P-CUSTOM ECF1 ATM Waistband FEM Savanna 320319 | 2025-06-16 |
| SIGVARIS INC | 861P-CUSTOM ECF1 ATM Waistband FEM °° Savanna 320355 | 2025-06-16 |
| SIGVARIS INC | 861P-CUSTOM ECF1 ATM Waistband FEM Grey 320397 | 2025-06-16 |
| SIGVARIS INC | 861P-CUSTOM ECF1 ATM Waistband FEM °° Grey 320433 | 2025-06-16 |
| SIGVARIS INC | 861P-CUSTOM ECF1 ATM Waistband FEM Caramel 320475 | 2025-06-16 |
| SIGVARIS INC | 861P-CUSTOM ECF1 ATM Waistband FEM °° Caramel 320511 | 2025-06-16 |
| SIGVARIS INC | 861P-CUSTOM ECF1 ATM Waistband FEM Black 320553 | 2025-06-16 |
| SIGVARIS INC | 861P-CUSTOM ECF1 ATM Waistband FEM °° Black 320589 | 2025-06-16 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD Quadrinova UNI °° Black 320593 | 2025-06-16 |
| SIGVARIS INC | PS1420 ETH1 Calf Essential Thermo CCL1 L L Nature ETH1D33176 | 2025-06-16 |
| SIGVARIS INC | PS1420 ETH1 Calf Essential Thermo CCL1 N L Nature ETH1D32176 | 2025-06-16 |
| SIGVARIS INC | PS1420 ETH1 Calf Essential Thermo CCL1 L M Nature ETH1D23176 | 2025-06-16 |
| SIGVARIS INC | PS1420 ETH1 Calf Essential Thermo CCL1 N M Nature ETH1D22176 | 2025-06-16 |
| SIGVARIS INC | PS1420 ETH1 Calf Essential Thermo CCL1 L S Nature ETH1D13176 | 2025-06-16 |
| SIGVARIS INC | PS1420 ETH1 Calf Essential Thermo CCL1 N S Nature ETH1D12176 | 2025-06-16 |
| SIGVARIS INC | PS1420 ETH1 Calf Essential Thermo CCL1 L XS Nature ETH1D03176 | 2025-06-16 |
| SIGVARIS INC | PS1420 ETH1 Calf Essential Thermo CCL1 N XS Nature ETH1D02176 | 2025-06-16 |
| SIGVARIS INC | 832C Style Pattern 20-30mmHg W SS GraphiteConfetti 832CSSW06 | 2025-06-16 |
| SIGVARIS INC | 832C Style Pattern 20-30mmHg W SL GraphiteConfetti 832CSLW06 | 2025-06-16 |
| SIGVARIS INC | 832C Style Pattern 20-30mmHg W MS GraphiteConfetti 832CMSW06 | 2025-06-16 |
| SIGVARIS INC | 832C Style Pattern 20-30mmHg W ML GraphiteConfetti 832CMLW06 | 2025-06-16 |
| SIGVARIS INC | 832C Style Pattern 20-30mmHg W LS GraphiteConfetti 832CLSW06 | 2025-06-16 |
| SIGVARIS INC | 832C Style Pattern 20-30mmHg W LL GraphiteConfetti 832CLLW06 | 2025-06-16 |
| SIGVARIS INC | 832C Style Pattern 20-30mmHg M SS GraphiteConfetti 832CSSM06 | 2025-06-16 |
| SIGVARIS INC | 832C Style Pattern 20-30mmHg M SL GraphiteConfetti 832CSLM06 | 2025-06-16 |
| SIGVARIS INC | 832C Style Pattern 20-30mmHg M MS GraphiteConfetti 832CMLM06 | 2025-06-16 |
| SIGVARIS INC | 832C Style Pattern 20-30mmHg M ML GraphiteConfetti 832CMLM06 | 2025-06-16 |
| SIGVARIS INC | 832C Style Pattern 20-30mmHg M LS GraphiteConfetti 832CLSM06 | 2025-06-16 |
| SIGVARIS INC | 832C Style Pattern 20-30mmHg M LL GraphiteConfetti 832CLLM06 | 2025-06-16 |
| SIGVARIS INC | 861P-CUSTOM ECF1 ATB Bodypart FEM °° marine 355548 | 2025-05-20 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT1L SoftTop MEN marine 355511 | 2025-05-20 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT1L SoftTop MEN Skin 320238 | 2025-05-20 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT1L SoftTop MEN °° Skin 320274 | 2025-05-20 |
| SIGVARIS INC | 861P-CUSTOM ECF1 ATB Bodypart FEM °° Skin 320275 | 2025-05-20 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT1L SoftTop MEN Savanna 320316 | 2025-05-20 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT1L SoftTop MEN °° Savanna 320352 | 2025-05-20 |
| SIGVARIS INC | 861P-CUSTOM ECF1 ATB Bodypart FEM °° Savanna 320353 | 2025-05-20 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT1L SoftTop MEN Grey 320394 | 2025-05-20 |
| SIGVARIS INC | 861P-CUSTOM ECF1 ATB Bodypart FEM °° Grey 320431 | 2025-05-20 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT1L SoftTop MEN Caramel 320472 | 2025-05-20 |
| SIGVARIS INC | 861P-CUSTOM ECF1 ATB Bodypart FEM °° Caramel 320509 | 2025-05-20 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT1L SoftTop MEN Black 320550 | 2025-05-20 |
| SIGVARIS INC | 861P-CUSTOM ECF1 ATB Bodypart FEM °° Black 320587 | 2025-05-20 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT1L SoftTop MEN °° marine 355547 | 2025-05-19 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT1L SoftTop MEN °° Grey 320430 | 2025-05-19 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT1L SoftTop MEN °° Caramel 320508 | 2025-05-19 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT1L SoftTop MEN °° Black 320586 | 2025-05-12 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT1L SoftTop FEM marine 355510 | 2025-05-01 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT1L SoftTop FEM Skin 320237 | 2025-05-01 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT1L SoftTop FEM Savanna 320315 | 2025-05-01 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT1L SoftTop FEM Grey 320393 | 2025-05-01 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT1L SoftTop FEM Caramel 320471 | 2025-05-01 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT1L SoftTop FEM Black 320549 | 2025-05-01 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT1L SoftTop FEM °° marine 355546 | 2025-04-22 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT1L SoftTop FEM °° Skin 320273 | 2025-04-22 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT1L SoftTop FEM °° Savanna 320351 | 2025-04-22 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT1L SoftTop FEM °° Grey 320429 | 2025-04-22 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT1L SoftTop FEM °° Caramel 320507 | 2025-04-22 |
| SIGVARIS INC | 861P-CUSTOM ECF1 AT1L SoftTop FEM °° Black 320585 | 2025-04-22 |
| 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 °° 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. [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 |