Contract manufacturerHART ENTERPRISES, INC. (Sparta, MI)MichiganAnesthesiologyCardiovascularGeneral and plastic surgeryGastroenterology and urologyClass IIClass I
HART ENTERPRISES, INC.
Contract manufacturer ยท Sparta, MI
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1828424 (openFDA record; or search FDA's registration database)
- FEI number
- 1828424
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- HART ENTERPRISES, INC. (FDA owner/operator no. 1828424)
- Registered address
- 400 APPLEJACK CT., Sparta, MI 49345
- Contract listings
- 10 device listings, 9 product codes, first listed Apr 11, 2002
- 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 |
|---|---|---|---|---|---|
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | Class II | Anesthesiology | Contract manufacturing | Dec 14, 2007 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | Class II | Cardiovascular | Contract manufacturing | Aug 7, 2012 |
| DWO | Needle, Biopsy, Cardiovascular | Class I | General and plastic surgery | Contract manufacturing | Dec 14, 2007 |
| DYB | Introducer, Catheter | Class II | Cardiovascular | Contract manufacturing | Dec 14, 2007 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | Class II | Gastroenterology and urology | Contract manufacturing | Aug 28, 2026 |
| GAA | Needle, Aspiration And Injection, Disposable | Class I | General and plastic surgery | Contract manufacturing | Dec 14, 2007 |
| GBZ | Catheter, Cholangiography | Class I | General and plastic surgery | Contract manufacturing | Apr 11, 2002 |
| GDM | Needle, Aspiration And Injection, Reusable | Class I | General and plastic surgery | Contract manufacturing | Dec 14, 2007 |
| KGZ | Accessories, Catheter | Class I | General and plastic surgery | Contract manufacturing | Nov 29, 2012 |