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 | Chipsleeve Arm No Hand XXL Short RT 2635-ANS-R | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand XXL Short LT 2635-ANS-L | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand XXL Reg RT 2635-ANR-R | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand XXL Reg LT 2635-ANR-L | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand XXL Long RT 2635-ANL-R | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand XXL Long LT 2635-ANL-L | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand XL Short RT 2634-ANS-R | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand XL Short LT 2634-ANS-L | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand XL Reg RT 2634-ANR-R | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand XL Reg LT 2634-ANR-L | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand XL Long RT 2634-ANL-R | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand XL Long LT 2634-ANL-L | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand LG Short RT 2633-ANS-R | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand LG Short LT 2633-ANS-L | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand LG Reg RT 2633-ANR-R | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand LG Reg LT 2633-ANR-L | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand LG Long RT 2633-ANL-R | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand LG Long LT 2633-ANL-L | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand MD Short RT 2632-ANS-R | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand MD Short LT 2632-ANS-L | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand MD Reg RT 2632-ANR-R | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand MD Reg LT 2632-ANR-L | 2026-01-19 |
| SIGVARIS INC | Chipsleeve Arm No Hand MD Long RT 2632-ANL-R | 2026-01-19 |
| 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 | 862C-CUSTOM ECF2 AD SoftTop UNI °° marine 355557 | 2026-01-16 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD SoftTop UNI marine 355518 | 2026-01-16 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD SoftTop UNI Skin 320245 | 2026-01-16 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD SoftTop UNI °° Skin 320284 | 2026-01-16 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD SoftTop UNI Savanna 320323 | 2026-01-16 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD SoftTop UNI °° Savanna 320362 | 2026-01-16 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD SoftTop UNI Grey 320401 | 2026-01-16 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD SoftTop UNI °° Grey 320440 | 2026-01-16 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD SoftTop UNI Caramel 320479 | 2026-01-16 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD SoftTop UNI °° Caramel 320518 | 2026-01-16 |
| SIGVARIS INC | 862C-CUSTOM ECF2 AD SoftTop UNI Black 320557 | 2026-01-16 |
| SIGVARIS INC | 252C Linen 20-30mmHg W SS Sandstone 252CSSW220 | 2026-01-16 |
| SIGVARIS INC | 252C Linen 20-30mmHg M SS Sandstone 252CSSM220 | 2026-01-16 |
| SIGVARIS INC | 252C Linen 20-30mmHg W SL Sandstone 252CSLW220 | 2026-01-16 |
| SIGVARIS INC | 252C Linen 20-30mmHg M SL Sandstone 252CSLM220 | 2026-01-16 |
| SIGVARIS INC | 252C Linen 20-30mmHg W MS Sandstone 252CMSW220 | 2026-01-16 |
| SIGVARIS INC | 252C Linen 20-30mmHg M MS Sandstone 252CMSM220 | 2026-01-16 |
| SIGVARIS INC | 252C Linen 20-30mmHg W ML Sandstone 252CMLW220 | 2026-01-16 |
| SIGVARIS INC | 252C Linen 20-30mmHg M ML Sandstone 252CMLM220 | 2026-01-16 |
| SIGVARIS INC | 252C Linen 20-30mmHg W LS Sandstone 252CLSW220 | 2026-01-16 |
| SIGVARIS INC | 252C Linen 20-30mmHg M LS Sandstone 252CLSM220 | 2026-01-16 |
| SIGVARIS INC | 252C Linen 20-30mmHg W LL Sandstone 252CLLW220 | 2026-01-16 |
| SIGVARIS INC | 252C Linen 20-30mmHg M LL Sandstone 252CLLM220 | 2026-01-16 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg XS Stone Blue 262CXS218 | 2026-01-16 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg XL Stone Blue 262CXL218 | 2026-01-16 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg XL Ivory 262CXL217 | 2026-01-16 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg XS Ivory 262CXS217 | 2026-01-16 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg LL Stone Blue 262CLL218 | 2026-01-16 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg LS Stone Blue 262CLS218 | 2026-01-16 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg ML Stone Blue 262CML218 | 2026-01-16 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg MS Stone Blue 262CMS218 | 2026-01-16 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg SL Stone Blue 262CSL218 | 2026-01-16 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg SS Stone Blue 262CSS218 | 2026-01-16 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg LL Ivory 262CLL217 | 2026-01-16 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg LS Ivory 262CLS217 | 2026-01-16 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg ML Ivory 262CML217 | 2026-01-16 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg MS Ivory 262CMS217 | 2026-01-16 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg SL Ivory 262CSL217 | 2026-01-16 |
| SIGVARIS INC | 262C Style Bamboo 20-30mmHg SS Ivory 262CSS217 | 2025-12-16 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U ML Blue 442CML50 | 2025-09-29 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U LS Blue 442CLS50 | 2025-09-29 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U LM Blue 442CLM50 | 2025-09-29 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U LL Blue 442CLL50 | 2025-09-29 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U SS Black 442CSS99 | 2025-09-29 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U SM Black 442CSM99 | 2025-09-29 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U SL Black 442CSL99 | 2025-09-29 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U MS Black 442CMS99 | 2025-09-29 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U MM Black 442CMM99 | 2025-09-29 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U ML Black 442CML99 | 2025-09-29 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U LS Black 442CLS99 | 2025-09-29 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U LM Black 442CLM99 | 2025-09-29 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U LL Black 442CLL99 | 2025-09-29 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U SS Pink 442CSS56 | 2025-09-29 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U SM Pink 442CSM56 | 2025-09-29 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U SL Pink 442CSL56 | 2025-09-29 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U MS Pink 442CMS56 | 2025-09-29 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U MM Pink 442CMM56 | 2025-09-29 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U ML Pink 442CML56 | 2025-09-29 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U LS Pink 442CLS56 | 2025-09-29 |
| SIGVARIS INC | 442C Motion UP25 20-30 mmHg U LM Pink 442CLM56 | 2025-09-29 |
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 |