Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003018722

FEI Number

3003018722

Entity Name

ENERCON TECHNOLOGIES

City/State/Country

GRAY, ME, US

Establishment Address

25 NORTHBROOK DR., P.O. BOX 665, GRAY, ME 04039, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ENERCON TECHNOLOGIES (Owner Number: 9051058)

Owner / Operator Contact Address

25 NORTHBROOK DR., P.O. BOX 665, Gray, ME 04039, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2018-01-10
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2018-01-10
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2018-01-10
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2015-02-02
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2015-02-02
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2015-02-02
BYR	Transducer, Gas Pressure, Differential	Anesthesiology	Class 1	868.2875	2024-11-19
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2019-12-20
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2015-10-16
PGX	Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System	Microbiology	Class 2	866.2680	2015-10-16
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2015-10-16
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2015-10-16
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2019-02-07
EFD	Amalgamator, Dental, Ac-Powered	Dental	Class 1	872.3100	2021-06-02
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2021-06-22
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2021-06-22
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-06-22

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ENERCON TECHNOLOGIES

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0042-2025	Luminex Molecular Diagnostics Inc	2	NxTAG Respiratory Pathogen Panel, REF: I051C0447

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003018722. Last updated year: 2026. Please use registration number 3003018722 when referencing this establishment in official correspondence.