Otoscope (ERA) contract manufacturers
7 US facilities list FDA product code ERA as a contract manufacturer (7) or contract sterilizer (0).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Otoscope
- Product code
- ERA (FDA product classification database)
- Device class
- Class I
- Regulation
- 21 CFR 874.4770
- Classification panel
- Ear, nose and throat
Where they are
Massachusetts 3 · Florida 1 · Nebraska 1 · New York 1 · Wisconsin 1
All 7 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| EVCO Plastics-AMP | 3009590187 | Contract manufacturer | Ear, nose and throat | Deforest, WI | Not verified | Oct 21, 2026 |
| HENKE SASS WOLF OF AMERICA, INC. | 1222997 | Contract manufacturer | Ear, nose and throat; Gastroenterology and urology; Orthopedic | Dudley, MA | Not verified | Oct 21, 2026 |
| KARL STORZ ENDOVISION, INC. | 1221826 | Contract manufacturer | Gastroenterology and urology; Ear, nose and throat; Obstetrics and gynecology +4 more | Charlton, MA | Not verified | Oct 21, 2026 |
| PIVOT - EDM | 3014903258 | Contract manufacturer | General and plastic surgery; Ear, nose and throat; Physical medicine | La Vista, NE | Not verified | Oct 21, 2026 |
| PRECISION OPTICS CORP. | 1222616 | Contract manufacturer | Ear, nose and throat; Ophthalmic; General and plastic surgery +3 more | Gardner, MA | Not verified | Oct 21, 2026 |
| SYNCRON EMS, LLC | 3014339847 | Contract manufacturer | Ear, nose and throat | Palm Bay, FL | Not verified | Oct 21, 2026 |
| TESSY PLASTICS CORP. | 1317202 | Contract manufacturer | Clinical chemistry; General and plastic surgery; Ear, nose and throat +3 more | Elbridge, NY | Not verified | Oct 21, 2026 |
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- EOQ Bronchoscope (Flexible Or Rigid) (22)
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- EOB Nasopharyngoscope (Flexible Or Rigid) (15)