Amuchina Intl., Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Amuchina Intl., Inc. makes
Amuchina Intl., Inc. manufactures disinfectant solutions for peritoneal dialysis, including AMUKIN D and AMUKIN-50% for continuous ambulatory peritoneal dialysis (CAPD) Y-sets, as well as dialyzer disinfectants like AMUCHINA/DIALYZER DISINFECTANT. The company also provides modified labeling for AMUKIN-50%.
These products are regulated under FDA 510(k) clearance, with device classifications spanning Class I and Class II. The company is based in the United States.
Catalogue
Amukin D Ref K992016
Regimes: 510(k) Registry: 510(k)Amukin-50% For Capd Y-Set Ref K862928
Regimes: 510(k) Registry: 510(k)Amuchina Ref K952302
Regimes: 510(k) Registry: 510(k)Amuchina/Dialyzer Disinfectant Ref K852359
Regimes: 510(k) Registry: 510(k)Modified Labeling For Amukin-50% Ref K871583
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Amuchina Intl., Inc. have in the registry?
The registry currently lists 5 devices for Amuchina Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Amuchina Intl., Inc.'s devices?
Among its 5 most recently registered devices, Amuchina Intl., Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Amuchina Intl., Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Amuchina Intl., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Amuchina Intl., Inc. in the registry?
The most recently registered devices listed for Amuchina Intl., Inc. include AMUKIN D, AMUKIN-50% FOR CAPD Y-SET, AMUCHINA and AMUCHINA/DIALYZER DISINFECTANT.