FDA Registration
Active
🇺🇸 United States
HENKE SASS WOLF OF AMERICA, INC.
Reg #: 1222997
·
FEI: 1000120548
·
Expires 2026
Products
4
Proprietary Names
7
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- HENKE SASS WOLF OF AMERICA, INC.
- Registration Number
- 1222997
- FEI Number
- 1000120548
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 135 Schofield Ave
- City
- DUDLEY
- State
- MA
- ZIP
- 01571
- Country
- US
Owner / Operator
- Firm Name
- HENKE-SASS WOLF, GMBH.
- Operator Number
- 8010418
- Address
- Keltenstrasse 1, --
- City
- TUTTLINGEN
- State
- Baden-Wurttemberg
- Postal Code
- D-78532
- Country
- DE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2016-04-11 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 1998-07-07 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2007-11-20 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2016-04-11 |
Proprietary Names
Laparoscope, general and plastic surgery
XION Laparoscopes
HSW Laparosopes & Accessories
XION Otoscope
HSW Arthroscope
Nasopharyngoscope (flexible / rigid)
Henke Sass Wolf of America Arthroscope
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)