Tanabe U.S.A., Inc.
Country not established
- Devices
- 8
What Tanabe U.S.A., Inc. makes
Tanabe U.S.A., Inc. manufactures a range of urodynamic disposable test strips under the UROPAPER EIKEN brand, including variants such as EIKEN HAG, EIKEN 7, EIKEN AG, and EIKEN GP. These products are designed for urinalysis testing, including the detection of bacteria, glucose, ketones, pH, protein, and blood in urine samples. They are intended for use in clinical and home settings to support diagnostic evaluations.
The company’s portfolio is classified under FDA Class II medical devices and is authorised via 510(k) clearance. These products are listed in the FDA’s 510(k) database as cleared for commercial distribution in the United States. The manufacturer is based in the US.
Catalogue
Uropaper Eiken Hag Ref K932366
Regimes: 510(k) Registry: 510(k)Uropaper Eiken 7 Ref K932369
Regimes: 510(k) Registry: 510(k)Uropaper Eiken AG Ref K932365
Regimes: 510(k) Registry: 510(k)Uropaper Eiken 8 Ref K932367
Regimes: 510(k) Registry: 510(k)Uropaper Eiken Gk Ref K932363
Regimes: 510(k) Registry: 510(k)Uropaper Eiken Gp Ref K932364
Regimes: 510(k) Registry: 510(k)Uropaper Eiken 6B Ref K932368
Regimes: 510(k) Registry: 510(k)Uropaper Ref K931897
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Tanabe U.S.A., Inc. have in the registry?
The registry currently lists 8 devices for Tanabe U.S.A., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tanabe U.S.A., Inc.'s devices?
Among its 8 most recently registered devices, Tanabe U.S.A., Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Tanabe U.S.A., Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Tanabe U.S.A., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Tanabe U.S.A., Inc. in the registry?
The most recently registered devices listed for Tanabe U.S.A., Inc. include UROPAPER EIKEN HAG, UROPAPER EIKEN 7, UROPAPER EIKEN AG and UROPAPER EIKEN 8.