Premier North America, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Premier North America, Inc. makes
Premier North America, Inc. manufactures medical devices including the BLU TOTALE and ENEO TOTALE, which are likely surgical drapes or adhesive barriers, as well as the NUNA LUX, a product potentially used for wound or skin preparation. The company also produces Avologi Gel Primer and Avologi ENEO, which appear to be skin preparation solutions or adhesives, and Luminice, a device possibly related to surgical lighting or illumination.
These devices fall under FDA Class II regulation and are supported by 510(k) clearances in the United States. The company is based in the US and its products are listed in the FDA’s 510(k) registry.
Catalogue
BLU TOTALE (Model: ENEOB852) Ref K232656
Regimes: 510(k) Registry: 510(k)Nuna Lux (NUNL528) Ref K233862
Regimes: 510(k) Registry: 510(k)Avologi Gel Primer (Model: Av25) Ref K220735
Regimes: 510(k) Registry: 510(k)Luminice Ref K214100
Regimes: 510(k) Registry: 510(k)ENEO TOTALE (Model: ENEOT947) Ref K213841
Regimes: 510(k) Registry: 510(k)Avologi ENEO Ref K181659
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Premier North America, Inc. have in the registry?
The registry currently lists 6 devices for Premier North America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Premier North America, Inc.'s devices?
Among its 6 most recently registered devices, Premier North America, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Premier North America, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Premier North America, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Premier North America, Inc. in the registry?
The most recently registered devices listed for Premier North America, Inc. include BLU TOTALE (Model: ENEOB852), NUNA LUX (NUNL528), Avologi Gel Primer (Model: Av25) and Luminice.