Amatech International, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What Amatech International, Inc. makes
Amatech International, Inc. manufactures glucose monitoring test strips (MD STRIPS BG) for blood glucose level assessment, as well as urine diagnostic reagent strips for rapid qualitative analysis of urinary conditions. The company also produces the AMASTIM 2000, a device for transcutaneous electrical nerve stimulation (TENS) therapy.
The company’s portfolio includes Class I and Class II devices, with several products authorised via the FDA’s 510(k) pathway. These devices are listed under US regulatory requirements, and the company operates from the United States.
Catalogue
Md Strips Bg Ref K875049
510(k) 510(k)Amastim 2000 Ref K872704
510(k) 510(k)Urine Diagnostic Reagent Strips Ref K862806
510(k) 510(k)
Frequently asked questions
How many devices does Amatech International, Inc. have in the registry?
The registry currently lists 3 devices for Amatech International, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Amatech International, Inc.'s devices?
Among its 3 most recently registered devices, Amatech International, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Amatech International, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Amatech International, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Amatech International, Inc. in the registry?
The most recently registered devices listed for Amatech International, Inc. include MD STRIPS BG, AMASTIM 2000 and URINE DIAGNOSTIC REAGENT STRIPS.