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 | 862N-CUSTOM ECF2 AG SensinovaUnisex UNI °° marine 355562 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG Quadrinova UNI °° marine 355561 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG Quadrinova UNI marine 355522 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG Micro knobbed band UNI Marine 355467 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG Micro knobbed band UNI Black 355466 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG Micro knobbed band UNI Savanna 355465 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG Micro knobbed band UNI Skin 355464 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG Micro knobbed band UNI Caramel 355463 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG Micro knobbed band UNI Grey 355462 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG Micro knobbed band UNI °° Marine 355461 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG Micro knobbed band UNI °° Savanna 355459 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG Micro knobbed band UNI °° Skin 355458 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG Micro knobbed band UNI °° Caramel 355457 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG Micro knobbed band UNI °° Grey 355456 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG Quadrinova UNI Skin 320249 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG Quadrinova UNI °° Skin 320288 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG Quadrinova UNI Savanna 320327 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG Quadrinova UNI °° Savanna 320366 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG SensinovaUnisex UNI °° Savanna 320367 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG Quadrinova UNI Grey 320405 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG Quadrinova UNI °° Grey 320444 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG SensinovaUnisex UNI °° Grey 320445 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG Quadrinova UNI Caramel 320483 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG Quadrinova UNI °° Caramel 320522 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG SensinovaUnisex UNI °° Caramel 320523 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG Quadrinova UNI Black 320561 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG Quadrinova UNI °° Black 320600 | 2026-03-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AG SensinovaUnisex UNI °° Black 320601 | 2026-03-27 |
| SIGVARIS INC | Sigvaris DOFF N’ DONNER SET – Single Unit 583D300 | 2026-03-19 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AF Quadrinova UNI °° marine 355558 | 2026-01-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AF Quadrinova UNI marine 355519 | 2026-01-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AF Quadrinova UNI Skin 320246 | 2026-01-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AF Quadrinova UNI °° Skin 320285 | 2026-01-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AF Quadrinova UNI Savanna 320324 | 2026-01-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AF Quadrinova UNI °° Savanna 320363 | 2026-01-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AF Quadrinova UNI Grey 320402 | 2026-01-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AF Quadrinova UNI °° Grey 320441 | 2026-01-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AF Quadrinova UNI Caramel 320480 | 2026-01-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AF Quadrinova UNI °° Caramel 320519 | 2026-01-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AF Quadrinova UNI Black 320558 | 2026-01-27 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AF SensinovaUnisex UNI °° Black 320598 | 2026-01-27 |
| SIGVARIS INC | 579 Melany Donning & Doffing Extra Small 579MXS | 2026-01-27 |
| SIGVARIS INC | 579 Melany Donning & Doffing Small 579MSM | 2026-01-27 |
| SIGVARIS INC | Washing Solution 6 Pack of 16 oz Bottles 586W900 | 2026-01-27 |
| SIGVARIS INC | ECF SSG MTM CCL1/18-21 mmHg Shorts - 1 PC ECF1 ET Bodypart UNI °° marine 355553 | 2026-01-26 |
| SIGVARIS INC | ECF SSG MTM CCL1/18-21 mmHg Legging - 1 PC ECF1 BT Bodypart UNI °° marine 355552 | 2026-01-26 |
| SIGVARIS INC | ECF SSG MTM CCL1/18-21 mmHg Capri pants - 1 PC ECF1 B1T Bodypart UNI °° marine 355551 | 2026-01-26 |
| SIGVARIS INC | ECF SSG MTM CCL1/18-21 mmHg Capri pants - 1 PC ECF1 B1T Bodypart UNI °° Skin 320278 | 2026-01-26 |
| SIGVARIS INC | ECF SSG MTM CCL1/18-21 mmHg Legging - 1 PC ECF1 BT Bodypart UNI °° Skin 320279 | 2026-01-26 |
| SIGVARIS INC | ECF SSG MTM CCL1/18-21 mmHg Shorts - 1 PC ECF1 ET Bodypart UNI °° Skin 320280 | 2026-01-26 |
| SIGVARIS INC | ECF SSG MTM CCL1/18-21 mmHg Capri pants - 1 PC ECF1 B1T Bodypart UNI °° Savanna 320356 | 2026-01-26 |
| SIGVARIS INC | ECF SSG MTM CCL1/18-21 mmHg Legging - 1 PC ECF1 BT Bodypart UNI °° Savanna 320357 | 2026-01-26 |
| SIGVARIS INC | ECF SSG MTM CCL1/18-21 mmHg Shorts - 1 PC ECF1 ET Bodypart UNI °° Savanna 320358 | 2026-01-26 |
| SIGVARIS INC | ECF SSG MTM CCL1/18-21 mmHg Capri pants - 1 PC ECF1 B1T Bodypart UNI °° Grey 320434 | 2026-01-26 |
| SIGVARIS INC | ECF SSG MTM CCL1/18-21 mmHg Legging - 1 PC ECF1 BT Bodypart UNI °° Grey 320435 | 2026-01-26 |
| SIGVARIS INC | ECF SSG MTM CCL1/18-21 mmHg Shorts - 1 PC ECF1 ET Bodypart UNI °° Grey 320436 | 2026-01-26 |
| SIGVARIS INC | ECF SSG MTM CCL1/18-21 mmHg Capri pants - 1 PC ECF1 B1T Bodypart UNI °° Caramel 320512 | 2026-01-26 |
| SIGVARIS INC | ECF SSG MTM CCL1/18-21 mmHg Legging - 1 PC ECF1 BT Bodypart UNI °° Caramel 320513 | 2026-01-26 |
| SIGVARIS INC | ECF SSG MTM CCL1/18-21 mmHg Shorts - 1 PC ECF1 ET Bodypart UNI °° Caramel 320514 | 2026-01-26 |
| SIGVARIS INC | ECF SSG MTM CCL1/18-21 mmHg Capri pants - 1 PC ECF1 B1T Bodypart UNI °° Black 320590 | 2026-01-26 |
| SIGVARIS INC | ECF SSG MTM CCL1/18-21 mmHg Legging - 1 PC ECF1 BT Bodypart UNI °° Black 320591 | 2026-01-26 |
| SIGVARIS INC | ECF SSG MTM CCL1/18-21 mmHg Shorts - 1 PC ECF1 ET Bodypart UNI °° Black 320592 | 2026-01-26 |
| SIGVARIS INC | 862N-CUSTOM ECF2 AF Quadrinova UNI °° Black 320597 | 2026-01-26 |
| SIGVARIS INC | 252C Linen 20-30mmHg W SS Eucalyptus 252CSSW221 | 2026-01-21 |
| SIGVARIS INC | 252C Linen 20-30mmHg M SS Eucalyptus 252CSSM221 | 2026-01-21 |
| SIGVARIS INC | 252C Linen 20-30mmHg W SL Eucalyptus 252CSLW221 | 2026-01-21 |
| SIGVARIS INC | 252C Linen 20-30mmHg M SL Eucalyptus 252CSLM221 | 2026-01-21 |
| SIGVARIS INC | 252C Linen 20-30mmHg W MS Eucalyptus 252CMSW221 | 2026-01-21 |
| SIGVARIS INC | 252C Linen 20-30mmHg M MS Eucalyptus 252CMSM221 | 2026-01-21 |
| SIGVARIS INC | 252C Linen 20-30mmHg W ML Eucalyptus 252CMLW221 | 2026-01-21 |
| SIGVARIS INC | 252C Linen 20-30mmHg M ML Eucalyptus 252CMLM221 | 2026-01-21 |
| SIGVARIS INC | 252C Linen 20-30mmHg W LS Eucalyptus 252CLSW221 | 2026-01-21 |
| SIGVARIS INC | 252C Linen 20-30mmHg M LS Eucalyptus 252CLSM221 | 2026-01-21 |
| SIGVARIS INC | 252C Linen 20-30mmHg W LL Eucalyptus 252CLLW221 | 2026-01-21 |
| SIGVARIS INC | 252C Linen 20-30mmHg M LL Eucalyptus 252CLLM221 | 2026-01-21 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg XL Black 262CXL199 | 2026-01-21 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg XS Black 262CXS199 | 2026-01-21 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg LL Black 262CLL199 | 2026-01-21 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg LS Black 262CLS199 | 2026-01-21 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg ML Black 262CML199 | 2026-01-21 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg MS Black 262CMS199 | 2026-01-21 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg SL Black 262CSL199 | 2026-01-21 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg SS Black 262CSS199 | 2026-01-21 |
| SIGVARIS INC | Chipsleeve Arm No Hand MD Long LT 2632-ANL-L | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand SM Short RT 2631-ANS-R | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand SM Short LT 2631-ANS-L | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand SM Reg RT 2631-ANR-R | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand SM Reg LT 2631-ANR-L | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand SM Long RT 2631-ANL-R | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand SM Long LT 2631-ANL-L | 2026-01-19 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg XL Dusk Violet 262CXL219 | 2026-01-19 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg XS Dusk Violet 262CXS219 | 2026-01-19 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg LL Dusk Violet 262CLL219 | 2026-01-19 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg LS Dusk Violet 262CLS219 | 2026-01-19 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg ML Dusk Violet 262CML219 | 2026-01-19 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg MS Dusk Violet 262CMS219 | 2026-01-19 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg SL Dusk Violet 262CSL219 | 2026-01-19 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg SS Dusk Violet 262CSS219 | 2026-01-19 |
| SIGVARIS INC | 579 Melany Donning & Doffing MEDIUM 579MMD | 2026-01-19 |
| SIGVARIS INC | 579 Melany Donning & Doffing Large 579MLG | 2026-01-19 |
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 |