Contract manufacturerContract sterilizerMedegen Medical Products (Gallaway, TN)TennesseeGeneral hospitalHematologyGeneral and plastic surgeryPathologyClass IIClass I
Medegen Medical Products
Contract manufacturer and sterilizer ยท Gallaway, TN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1043646 (openFDA record; or search FDA's registration database)
- FEI number
- 1043646
- Registered for
- FDA registration year 2026
- Establishment types
- Specification developer; Manufacturer; Contract manufacturer; Repackager or relabeler; Contract sterilizer
- Owner or operator
- Medegen Medical Products (FDA owner/operator no. 9005738)
- Registered address
- 209 MEDEGEN DR., Gallaway, TN 38036
- Contract listings
- 7 device listings, 7 product codes, first listed Aug 31, 2001
- 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 |
|---|---|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | Class II | General hospital | Contract manufacturing | Feb 11, 2010 |
| FNY | Basin, Emesis | Class I | General hospital | Contract manufacturing | Aug 31, 2001 |
| KIZ | Dish, Tissue Culture | Class I | Hematology | Contract manufacturing | Feb 11, 2010 |
| KIZ | Dish, Tissue Culture | Class I | Hematology | Contract sterilization | Feb 11, 2010 |
| KYW | Container, Liquid Medication, Graduated | Class I | General hospital | Contract manufacturing | Aug 31, 2001 |
| KYX | Dispenser, Liquid Medication | Class I | General hospital | Contract manufacturing | Jan 21, 2010 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract manufacturing | May 4, 2011 |
| NNI | Container, Specimen, Non-Sterile | Class I | Pathology | Contract manufacturing | Jan 8, 2010 |