Keilei Intl., Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Keilei Intl., Inc. makes
Keilei Intl., Inc. manufactures sterile and non-sterile gauze products for wound care and surgical applications, including roll bandages, sponges, and packing materials. Their portfolio also includes X-ray detectable gauze sponges designed for use in procedures requiring radiographic imaging.
The company’s devices are classified under FDA Class I and Class II (Unclassified), with most products listed via the 510(k) pathway. These products are intended for use in the United States, where regulatory compliance is maintained through FDA registration and clearance processes.
Catalogue
Bandage Roll, Gauze Ref K913779
Regimes: 510(k) Registry: 510(k)Gauze Sponge Ref K895086
Regimes: 510(k) Registry: 510(k)X-Ray Detectable Gauze Sponge Ref K895372
Regimes: 510(k) Registry: 510(k)Gauze Sponge, Sterile 2'S Ref K912779
Regimes: 510(k) Registry: 510(k)Gauze Packing, Surgical Sterile And Non-Sterile Ref K913575
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Keilei Intl., Inc. have in the registry?
The registry currently lists 5 devices for Keilei Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Keilei Intl., Inc.'s devices?
Among its 5 most recently registered devices, Keilei Intl., Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Keilei Intl., Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Keilei Intl., Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Keilei Intl., Inc. in the registry?
The most recently registered devices listed for Keilei Intl., Inc. include BANDAGE ROLL, GAUZE, GAUZE SPONGE, X-RAY DETECTABLE GAUZE SPONGE and GAUZE SPONGE, STERILE 2'S.