FDA Registration
Active
🇺🇸 United States
ENERCON TECHNOLOGIES
Reg #: 3003018722
·
FEI: 3003018722
·
Expires 2026
Products
13
Proprietary Names
12
Establishment Types
1
Classifications
13
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Registration Details
- Registration Name
- ENERCON TECHNOLOGIES
- Registration Number
- 3003018722
- FEI Number
- 3003018722
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 25 NORTHBROOK DR., P.O. BOX 665
- City
- GRAY
- State
- ME
- ZIP
- 04039
- Country
- US
Owner / Operator
- Firm Name
- ENERCON TECHNOLOGIES
- Operator Number
- 9051058
- Address
- 25 NORTHBROOK DR., P.O. BOX 665
- City
- Gray
- State
- ME
- Postal Code
- 04039
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Influenza A And Influenza B Multiplex Nucleic Acid Assay | OZE | Class 2 | Microbiology | No | 2018-01-10 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2018-01-10 |
| Respiratory Virus Panel Nucleic Acid Assay System | OCC | Class 2 | Microbiology | No | 2018-01-10 |
| Choledochoscope And Accessories, Flexible/Rigid | FBN | Class 2 | Gastroenterology, Urology | No | 2015-02-02 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2015-02-02 |
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2015-02-02 |
| Transducer, Gas Pressure, Differential | BYR | Class 1 | Anesthesiology | No | 2024-11-19 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2019-12-20 |
| Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | PGX | Class 2 | Microbiology | No | 2015-10-16 |
| Warmer, Thermal, Infusion Fluid | LGZ | Class 2 | General Hospital | No | 2019-02-07 |
| Amalgamator, Dental, Ac-Powered | EFD | Class 1 | Dental | No | 2021-06-02 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2023-12-28 |
| Shoulder Arthroplasty Implantation System | QHE | Class 2 | Orthopedic | No | 2025-06-05 |
Proprietary Names
Alere i Influenza A&B; Alere i Instrument
SpyGlass DS Digital Controller
BlueHale Pro
Influenza A and influenza B multiplex nucleic acid assay
real time Nucleic acid amplification system
Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system
Respiratory virus panel nucleic acid assay system
Warmer, Thermal, Infusion Fluid
VIALMIX®RFID
VIALMIX
MouthWatch HD PLUS+ Intraoral Camera
CORE Shoulder System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)