FDA Registration
Active
🇺🇸 United States
BioHealx Anal Fistula Device
Reg #: 3038193698
·
FEI: 3038193698
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Signum Surgical USA, Inc.
- Registration Number
- 3038193698
- FEI Number
- 3038193698
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 175 Strafford Ave Ste One
- City
- Wayne
- State
- PA
- ZIP
- 19087
- Country
- US
Regulatory Submissions
- 510(k) Number
- DEN240007
Owner / Operator
- Firm Name
- Signum Surgical Limited
- Operator Number
- 10092825
- Address
- Signum Surgical Limited, New Docks, Port of Galway
- City
- Galway
- State
- Galway (City)
- Postal Code
- H91NNY6
- Country
- IE
- Correspondent
- Moshe Zilversmit
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Anal Fistula Closure Device | QML | Class 2 | General, Plastic Surgery | No | 2025-02-23 |
Proprietary Names
BioHealx Anal Fistula Device
Establishment Types
Repack or Relabel Medical Device