Amniotome (HGE) contract manufacturers
7 US facilities list FDA product code HGE as a contract manufacturer (2) or contract sterilizer (5).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Amniotome
- Product code
- HGE (FDA product classification database)
- Device class
- Class I
- Regulation
- 21 CFR 884.4530
- Classification panel
- Obstetrics and gynecology
Where they are
Tennessee 3 · Alabama 1 · Illinois 1 · New Jersey 1 · New York 1
All 7 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| ADVANCED PRODUCT SOLUTIONS INC. | 3018071447 | Contract manufacturer | General and plastic surgery; Obstetrics and gynecology; General hospital +2 more | Dothan, AL | Not verified | Oct 21, 2026 |
| DeRoyal Industries, Inc. | 1054241 | Contract sterilizer | General and plastic surgery; General hospital; Gastroenterology and urology +14 more | New Tazewell, TN | Not verified | Oct 21, 2026 |
| DEROYAL INDUSTRIES, INC. | 1055236 | Contract sterilizer | General and plastic surgery; General hospital; Gastroenterology and urology +14 more | New Tazewell, TN | Not verified | Oct 21, 2026 |
| DeRoyal Industries, Inc. | 1057404 | Contract manufacturer | General hospital; General and plastic surgery; Obstetrics and gynecology +4 more | Powell, TN | Not verified | Oct 21, 2026 |
| Isomedix Operations Inc. | 2246552 | Contract sterilizer | General and plastic surgery; Orthopedic; Gastroenterology and urology +12 more | S Plainfield, NJ | Not verified | Oct 21, 2026 |
| MEDLINE INDUSTRIES, LP (Northpoint Services) | 1422634 | Contract sterilizer | General and plastic surgery; General hospital; Cardiovascular +10 more | Waukegan, IL | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1319639 | Contract sterilizer | Cardiovascular; General and plastic surgery; Gastroenterology and urology +14 more | Queensbury, NY | Not verified | Oct 21, 2026 |
Related obstetrics and gynecology product codes
- HET Laparoscope, Gynecologic (And Accessories) (30)
- HIF Insufflator, Laparoscopic (24)
- HIH Hysteroscope (And Accessories) (24)
- HGI Electrocautery, Gynecologic (And Accessories) (22)
- NUC Lubricant, Personal (22)
- LKF Cannula, Manipulator/Injector, Uterine (20)
- KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) (16)
- OHM Cesarean Section Tray (14)