FDA Registration
Active
🇺🇸 United States
SIGVARIS, INC.
Reg #: 1221770
·
FEI: 1221770
·
Expires 2026
Products
8
Proprietary Names
17
Establishment Types
4
Classifications
8
Registration Details
- Registration Name
- SIGVARIS, INC.
- Registration Number
- 1221770
- FEI Number
- 1221770
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1119 Highway 74 S
- City
- PEACHTREE CITY
- State
- GA
- ZIP
- 30269
- Country
- US
Owner / Operator
- Firm Name
- Sigvaris Holding AG
- Operator Number
- 8031005
- Address
- Sandgrube 29
- City
- Appenzell
- State
- Appenzell Innerrhoden
- Postal Code
- 9050
- Country
- CH
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2016-11-17 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2017-10-27 |
| Stocking, Elastic | ILG | Class 1 | Physical Medicine | No | 2016-11-17 |
| Binder, Elastic | KMO | Class 1 | General Hospital | No | 2016-11-17 |
| Binder, Medical, Therapeutic | MDR | Class 1 | General Hospital | No | 2016-11-17 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2025-01-13 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2023-11-21 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2001-11-05 |
Proprietary Names
Cotton Tubular
WaveFoam
Elasto-Soft
Non-Woven Padding
Biafoam
Biagrip Compressive
Biasoft
Compression Garments; Chipsleeve, Chipsleeve Custom, Medaform
Compression Garments (hand and foot); Compreboot Lite, Standard and Plus, Coolflex Standard Foot
Compression Garments; Compreshape and Compreshape Capri
Compression Garments (hand and foot); Medahand, Medaglove, Dorsal Pocket Glove
Compression Garments (hand and foot); Compreflex Reduce Foot, Medaboot, Secure Glove and Gauntlet
Compression Garments; Compreshorts, Compreshorts Capri, Custom and Capri Custom
Compression Garments; Compreflex Reduce, Coolflex Standard, Neck & Mandible Pad
Compression Garments; Comprevest, Custom only (Chipvest, Chipflow, Legassist, Armassist)
Inelastic Wraps, Compreflex Standard, Transition, Complete and Contain
Accessories, It Stays Adhesive
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device