Infrascan, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000003353 FEI 3006059345
- Devices
- 8
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
Catalogue
Infrascanner Ref 2000-1
Regimes: CE MDR Registry: EUDAMED- Regimes: CE MDR Registry: EUDAMEDGUDID
- Registry: GUDID
Infrascanner Ref K120949
Regimes: 510(k) Registry: 510(k)Infrascanner Model 2500 (Model 2500) Ref K241389
Regimes: 510(k) Registry: 510(k)Infrascanner Ref K211617
Regimes: 510(k) Registry: 510(k)Infrascanner, Model 1000 Ref DEN100002
Regimes: De Novo Registry: De NovoInfrascanner Ref K200203
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- US-MF-000003353
- FDA FEI number
- 3006059345
- DUNS number
- 153408179
- EUDAMED status
- Active
- EUDAMED registered name
- InfraScan, Inc.
- Registered address
- 600, N Jackson Street, 19063, Media, United States
- Website
- www.infrascanner.com
- [email protected]
- Phone
- +1 215 387 6784
- PRRC contact
- Tony Groch
Frequently asked questions
How many devices does Infrascan, Inc. have in the registry?
The registry currently lists 8 devices for Infrascan, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Infrascan, Inc.'s devices?
Among its 8 most recently registered devices, Infrascan, Inc. has devices listed in EUDAMED (2 devices), FDA 510(k) (5 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Infrascan, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Infrascan, Inc.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Infrascan, Inc. in the registry?
The most recently registered devices listed for Infrascan, Inc. include Infrascanner, Infrascanner 2000, Infrascanner 2500 and Infrascanner Model 2500 (Model 2500).