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 | 183C MicroFiber Shades 15-20mmHg M C Blue Butterflies 183CC24 | 2025-02-20 |
| SIGVARIS INC | 183C MicroFiber Shades 15-20mmHg M B BlueButterfly 183CB24 | 2025-02-20 |
| SIGVARIS INC | 183C MicroFiber Shades 15-20mmHg M A BlueButterfly 183CA24 | 2025-02-20 |
| SIGVARIS INC | 143C MicroFiber Shades 15-20mmHg W C BlueButterfly 143CC24 | 2025-02-20 |
| SIGVARIS INC | 143C MicroFiber Shades 15-20mmHg W B BlueButterfly 143CB24 | 2025-02-20 |
| SIGVARIS INC | 143C MicroFiber Shades 15-20mmHg W A BlueButterfly 143CA24 | 2025-02-20 |
| SIGVARIS INC | Cflex Contain Full Leg MD MD MD Reg Right Black 340222-THR-R | 2025-02-20 |
| SIGVARIS INC | DOFF N DONNER CONE 358497 | 2025-02-04 |
| SIGVARIS INC | DOFF n DONNER ROLLY 358496 | 2025-02-04 |
| SIGVARIS INC | 579 Melany Donning & Doffing Extra Small 579MXS | 2025-02-04 |
| SIGVARIS INC | 579 Melany Donning & Doffing Small 579MSM | 2025-02-04 |
| SIGVARIS INC | 579 Melany Donning & Doffing MEDIUM 579MMD | 2025-02-04 |
| SIGVARIS INC | 579 Melany Donning & Doffing Large 579MLG | 2025-02-04 |
| SIGVARIS INC | 432 Motion Flow Tech 432CXL216 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CXS216 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CLL216 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CLS216 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CML216 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CMS216 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CSL216 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CSS216 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CXL215 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CXS215 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CLL215 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CLS215 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CML215 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CMS215 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CSL215 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CSS215 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CXL214 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CXS214 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CLL214 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CLS214 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CML214 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CMS214 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CSL214 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CSS214 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CXL213 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CXS213 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CLL213 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CLS213 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CML213 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CMS213 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CSL213 | 2025-01-28 |
| SIGVARIS INC | 432 Motion Flow Tech 432CSS213 | 2025-01-28 |
| SIGVARIS INC | OPTIFORM TOE CAPS / SILK LINING / SILK POCKET CCL2 358598 | 2024-12-30 |
| SIGVARIS INC | OPTIFORM TOE CAPS / SILK LINING CCL2 358597 | 2024-12-30 |
| SIGVARIS INC | OPTIFORM TOE CAPS / SILK POCKET CCL2 358596 | 2024-12-30 |
| SIGVARIS INC | OPTIFORM TOE CAPS / SILK LINING / SILK POCKET CCL1 358595 | 2024-12-30 |
| SIGVARIS INC | OPTIFORM TOE CAPS / SILK LINING CCL1 358594 | 2024-12-30 |
| SIGVARIS INC | OPTIFORM TOE CAPS / SILK POCKET CCL1 358593 | 2024-12-30 |
| SIGVARIS INC | OPTIFORM TOE CAPS CCL2 357291 | 2024-12-30 |
| SIGVARIS INC | OPTIFORM TOE CAPS CCL1 357290 | 2024-12-30 |
| SIGVARIS INC | 830 Microfiber Shades 832CSSM42 | 2024-12-04 |
| SIGVARIS INC | 830 Microfiber Shades 832CSLM42 | 2024-12-04 |
| SIGVARIS INC | 830 Microfiber Shades 832CMSM42 | 2024-12-04 |
| SIGVARIS INC | 830 Microfiber Shades 832CMLM42 | 2024-12-04 |
| SIGVARIS INC | 830 Microfiber Shades 832CLSM42 | 2024-12-04 |
| SIGVARIS INC | 830 Microfiber Shades 832CLLM42 | 2024-12-04 |
| SIGVARIS INC | 830 Microfiber Shades 832CSSW02 | 2024-12-04 |
| SIGVARIS INC | 830 Microfiber Shades 832CSLW02 | 2024-12-04 |
| SIGVARIS INC | 830 Microfiber Shades 832CMSW02 | 2024-12-04 |
| SIGVARIS INC | 830 Microfiber Shades 832CMLW02 | 2024-12-04 |
| SIGVARIS INC | 830 Microfiber Shades 832CLSW02 | 2024-12-04 |
| SIGVARIS INC | 830 Microfiber Shades 832CLLW02 | 2024-12-04 |
| SIGVARIS INC | 183 Microfiber Shades 183CC42 | 2024-12-04 |
| SIGVARIS INC | 183 Microfiber Shades 183CB42 | 2024-12-04 |
| SIGVARIS INC | 183 Microfiber Shades 183CA42 | 2024-12-04 |
| SIGVARIS INC | 143 Microfiber Shades 143CC02 | 2024-12-04 |
| SIGVARIS INC | 143 Microfiber Shades 143CB02 | 2024-12-04 |
| SIGVARIS INC | 143 Microfiber Shades 143CA02 | 2024-12-04 |
| SIGVARIS INC | Optiform Feel OFE1CE | 2024-11-21 |
| SIGVARIS INC | Optiform Feel OFE1CG | 2024-11-21 |
| SIGVARIS INC | Optiform Feel OFE1CH | 2024-11-21 |
| SIGVARIS INC | Optiform Feel OFE1CHH | 2024-11-21 |
| SIGVARIS INC | Optiform Feel OFE1ZX | 2024-11-21 |
| SIGVARIS INC | Optiform Feel OFE2AC1 | 2024-11-21 |
| SIGVARIS INC | Optiform Feel OFE2AE | 2024-11-21 |
| SIGVARIS INC | Optiform Feel OFE2AG | 2024-11-21 |
| SIGVARIS INC | Optiform Feel OFE2AH | 2024-11-21 |
| SIGVARIS INC | Optiform Feel OFE2AHH | 2024-11-21 |
| SIGVARIS INC | Optiform Feel OFE2CE | 2024-11-21 |
| SIGVARIS INC | Optiform Feel OFE2CG | 2024-11-21 |
| SIGVARIS INC | Optiform Feel OFE2CH | 2024-11-21 |
| SIGVARIS INC | Optiform Feel OFE2CHH | 2024-11-21 |
| SIGVARIS INC | Optiform Feel OFE3AC1 | 2024-11-21 |
| SIGVARIS INC | Optiform Feel OFE3AE | 2024-11-21 |
| SIGVARIS INC | Optiform Feel OFE3AG | 2024-11-21 |
| SIGVARIS INC | Optiform Feel OFE3AH | 2024-11-21 |
| SIGVARIS INC | Optiform Feel OFE3AHH | 2024-11-21 |
| SIGVARIS INC | Optiform Feel OFE3CE | 2024-11-21 |
| SIGVARIS INC | Optiform Feel OFE3CG | 2024-11-21 |
| SIGVARIS INC | Optiform Feel OFE3CH | 2024-11-21 |
| SIGVARIS INC | Optiform Feel OFE3CHH | 2024-11-21 |
| SIGVARIS INC | Optiform Hold OH4AB1 | 2024-11-21 |
| SIGVARIS INC | Optiform Hold OH4AD | 2024-11-21 |
| SIGVARIS INC | Optiform Hold OH4B1D | 2024-11-21 |
| SIGVARIS INC | Optiform Hold OH4BD | 2024-11-21 |
| SIGVARIS INC | Optiform Hold OH4CG | 2024-11-21 |
| SIGVARIS INC | Optiform Hold OH4EG | 2024-11-21 |
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 |