NewGen Surgical
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000032716 FEI 3010900528
- Devices
- 12
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
What NewGen Surgical makes
NewGen Surgical manufactures surgical bowls, sponge bowls, one-compartment trays, two-compartment trays, and emesis basins, including coated versions of the one-compartment tray.
These devices are classified as Class I and are listed in the EUDAMED registry; the company is based in the United States.
Catalogue
Search and filter all 12 devicesCompany details
- EUDAMED SRN
- US-MF-000032716
- FDA FEI number
- 3010900528
- EUDAMED status
- Active
- EUDAMED registered name
- NewGen Surgical
- Registered address
- 41, Simms St., 94901, San Rafael, United States
- Website
- www.newgensurgical.com
- facebook.com/NewGenSurgical
- [email protected]
- Phone
- +01 1 415 457 1138
- PRRC contact
- Alexis Boissiere
From the company website
We are on a mission to replace plastic with renewable materials across the healthcare ecosystem.
Frequently asked questions
How many devices does NewGen Surgical have in the registry?
The registry currently lists 12 devices for NewGen Surgical. Devices recorded under merged duplicate company entries are counted once.
Which registries list NewGen Surgical's devices?
Among its 12 most recently registered devices, NewGen Surgical has devices listed in EUDAMED (9 devices) and FDA GUDID (7 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do NewGen Surgical's devices fall under?
Among its 12 most recently registered devices, the classes recorded for NewGen Surgical's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from NewGen Surgical in the registry?
The most recently registered devices listed for NewGen Surgical include RBE Ring Basin - 5500 cc, Ring Basin - 5500 cc NGS5500RBE-80NS, Two Compartment Tray Coated NGS2CTC-250NS and One-Compartment Tray Coated NGS1CTC-250NS.