Contract manufacturerENERCON TECHNOLOGIES (Gray, ME)MaineAnesthesiologyDentalGastroenterology and urologyGeneral and plastic surgeryGeneral hospitalMicrobiologyClinical chemistryOrthopedicClass IClass II
ENERCON TECHNOLOGIES
Contract manufacturer ยท Gray, ME
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3003018722 (openFDA record; or search FDA's registration database)
- FEI number
- 3003018722
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- ENERCON TECHNOLOGIES (FDA owner/operator no. 9051058)
- Registered address
- 25 NORTHBROOK DR., P.O. BOX 665, Gray, ME 04039
- Contract listings
- 11 device listings, 13 product codes, first listed Feb 2, 2015
- 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 |
|---|---|---|---|---|---|
| BYR | Transducer, Gas Pressure, Differential | Class I | Anesthesiology | Contract manufacturing | Nov 19, 2024 |
| EFD | Amalgamator, Dental, Ac-Powered | Class I | Dental | Contract manufacturing | Jun 2, 2021 |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | Class II | Gastroenterology and urology | Contract manufacturing | Feb 2, 2015 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Class II | Gastroenterology and urology | Contract manufacturing | Dec 20, 2019 |
| KQM | Camera, Surgical And Accessories | Class I | General and plastic surgery | Contract manufacturing | Feb 2, 2015 |
| LGZ | Warmer, Thermal, Infusion Fluid | Class II | General hospital | Contract manufacturing | Feb 7, 2019 |
| NRD | Unit, Operative Dental, Accessories | Class I | Dental | Contract manufacturing | Dec 28, 2023 |
| NTN | Led Light Source | Class II | Gastroenterology and urology | Contract manufacturing | Feb 2, 2015 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | Class II | Microbiology | Contract manufacturing | Oct 16, 2015 |
| OOI | Real Time Nucleic Acid Amplification System | Class II | Clinical chemistry | Contract manufacturing | Oct 16, 2015 |
| OZE | Influenza A And Influenza B Multiplex Nucleic Acid Assay | Class II | Microbiology | Contract manufacturing | Oct 16, 2015 |
| PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | Class II | Microbiology | Contract manufacturing | Oct 16, 2015 |
| QHE | Shoulder Arthroplasty Implantation System | Class II | Orthopedic | Contract manufacturing | Jun 5, 2025 |