Contract manufacturerHENKE SASS WOLF OF AMERICA, INC. (Dudley, MA)MassachusettsEar, nose and throatGastroenterology and urologyOrthopedicClass IIClass I
HENKE SASS WOLF OF AMERICA, INC.
Contract manufacturer · Dudley, MA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1222997 (openFDA record; or search FDA's registration database)
- FEI number
- 1000120548
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- HENKE-SASS WOLF, GMBH. (FDA owner/operator no. 8010418)
- Registered address
- 135 Schofield Ave, Dudley, MA 01571
- Contract listings
- 4 device listings, 4 product codes, first listed Jul 7, 1998
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | Class II | Ear, nose and throat | Contract manufacturing | Apr 11, 2016 |
| ERA | Otoscope | Class I | Ear, nose and throat | Contract manufacturing | Jul 7, 1998 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract manufacturing | Nov 20, 2007 |
| HRX | Arthroscope | Class II | Orthopedic | Contract manufacturing | Nov 20, 2007 |