Contract manufacturerTHE HYGENIC COMPANY, LLC (Akron, OH)OhioDentalGastroenterology and urologyGeneral and plastic surgeryClass I
THE HYGENIC COMPANY, LLC
Contract manufacturer ยท Akron, OH
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1519375 (openFDA record; or search FDA's registration database)
- FEI number
- 1519375
- Registered for
- FDA registration year 2026
- Establishment types
- Specification developer; Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- The Hygenic Company, LLC (FDA owner/operator no. 1519375)
- Registered address
- 1245 HOME AVE., Akron, OH 44310
- Contract listings
- 3 device listings, 3 product codes, first listed Nov 15, 1977
- 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 |
|---|---|---|---|---|---|
| EIE | Dam, Rubber | Class I | Dental | Contract manufacturing | Nov 15, 1977 |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | Class I | Gastroenterology and urology | Contract manufacturing | Feb 27, 1998 |
| GAX | Tourniquet, Nonpneumatic | Class I | General and plastic surgery | Contract manufacturing | Sep 5, 1995 |