Fluxergy Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000010833 FEI 3016531205
- Devices
- 7
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- CMC Medical Devices & Drugs SLES
Catalogue
Fluxergy Analyzer Ref 5506-CE
Fluxergy Reaction Mix COVID-19 Ref 4155-CE
Fluxergy PCR Card Ref 8019
HVRe Influenza/RSV/SARS-CoV-2 Ref 8032
HVRe Influenza/RSV/SARS-CoV-2 Ref 8029
Company details
- EUDAMED SRN
- US-MF-000010833
- FDA FEI number
- 3016531205
- DUNS number
- 059765569
- EUDAMED status
- Active
- EUDAMED registered name
- Fluxergy Inc.
- Registered address
- 30, FAIRBANKS, 92618, IRVINE, United States
- Website
- www.fluxergy.com
- [email protected]
- PRRC contact
- NICK TRAN
What Fluxergy Inc. makes
Fluxergy Inc. manufactures diagnostic devices for molecular testing, including the Fluxergy Analyzer—a system for processing and analyzing nucleic acid samples—and the Fluxergy PCR Card, a disposable cartridge for polymerase chain reaction (PCR) assays. The company also produces the Fluxergy Reaction Mix COVID-19, a reagent for COVID-19 testing, as well as the Fluxergy Respiratory Specimen Collector for sample collection. Additionally, it offers the HVRe Influenza/RSV/SARS-CoV-2 test for detecting multiple respiratory pathogens.
The company’s devices are classified under Class A and In Vitro Diagnostic (IVD) General categories, with relevant products registered in the EU’s eudamed database. Fluxergy Inc. is headquartered in the United States.
Frequently asked questions
How many devices does Fluxergy Inc. have in the registry?
The registry currently lists 7 devices for Fluxergy Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fluxergy Inc.'s devices?
Among its 7 most recently registered devices, Fluxergy Inc. has devices listed in EUDAMED (7 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Fluxergy Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Fluxergy Inc.'s devices are IVDR Class A and IVD general. Each device page shows its own class and authorisation.
What are the newest devices from Fluxergy Inc. in the registry?
The most recently registered devices listed for Fluxergy Inc. include Fluxergy Analyzer, Fluxergy Respiratory Specimen Collector, Fluxergy Reaction Mix COVID-19 and Fluxergy PCR Card.