Norpak Mfg., Inc.
CanadaFDA applicant, unverified
- Devices
- 2
What Norpak Mfg., Inc. makes
Norpak Mfg., Inc. manufactures alcohol-based skin prep solutions and povidone-iodine prep products for surgical and procedural disinfection, as well as antifog solutions designed to prevent lens fogging in medical and industrial applications.
These products are regulated under FDA’s Class II and Class U device classifications, with relevant devices listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Alcohol Prep And Povidone-Iodine Prep Ref K896835
Regimes: 510(k) Registry: 510(k)Antifog Ref K934347
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Norpak Mfg., Inc. have in the registry?
The registry currently lists 2 devices for Norpak Mfg., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Norpak Mfg., Inc.'s devices?
Among its 2 most recently registered devices, Norpak Mfg., Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Norpak Mfg., Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Norpak Mfg., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Norpak Mfg., Inc. in the registry?
The most recently registered devices listed for Norpak Mfg., Inc. include ALCOHOL PREP AND POVIDONE-IODINE PREP and ANTIFOG.