System, Monitoring, Perinatal (HGM) contract manufacturers
5 US facilities list FDA product code HGM as a contract manufacturer (4) or contract sterilizer (1).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- System, Monitoring, Perinatal
- Product code
- HGM (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 884.2740
- Classification panel
- Obstetrics and gynecology
Where they are
Pennsylvania 2 · California 1 · Iowa 1 · Illinois 1
All 5 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| EDAN Diagnostics, Inc. | 3009499478 | Contract manufacturer | Cardiovascular; Anesthesiology; Obstetrics and gynecology +3 more | San Diego, CA | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc. | 1424263 | Contract sterilizer | Orthopedic; General and plastic surgery; Ophthalmic +13 more | Libertyville, IL | Not verified | Oct 21, 2026 |
| KATECHO LLC | 1930027 | Contract manufacturer | Cardiovascular; Neurology; Physical medicine +7 more | Des Moines, IA | Not verified | Oct 21, 2026 |
| Philips North America LLC | 3012528160 | Contract manufacturer | Cardiovascular; Anesthesiology; General hospital +2 more | Murrysville, PA | Not verified | Oct 21, 2026 |
| Philips North America LLC | 3016701404 | Contract manufacturer | Cardiovascular; Anesthesiology; General hospital +2 more | Export, PA | Not verified | Oct 21, 2026 |
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