Horiba, Ltd.
Country not established FDA
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Horiba, Ltd. makes
Horiba manufactures point-of-care diagnostic devices, including blood glucose meters (Yumizen C1200 series) with glucose and electrolyte measurement capabilities, such as sodium, potassium, and chloride electrodes. It also produces the PAROS CRP, a device for measuring C-reactive protein levels.
The company’s portfolio includes Class I and Class II devices, with regulatory submissions filed under the FDA’s 510(k) pathway. These products are listed in the FDA’s regulatory database, and the company operates with a US presence.
Catalogue
Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode Ref K183375
Regimes: 510(k) Registry: 510(k)Paros Crp Ref K022690
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Horiba Ltd. KYOTO · JP FEI 1000256526
Frequently asked questions
How many devices does Horiba, Ltd. have in the registry?
The registry currently lists 2 devices for Horiba, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Horiba, Ltd.'s devices?
Among its 2 most recently registered devices, Horiba, Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Horiba, Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Horiba, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Horiba, Ltd. in the registry?
The most recently registered devices listed for Horiba, Ltd. include Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode and PAROS CRP.
Which FDA establishments are linked to Horiba, Ltd.?
1 FDA establishment is linked to Horiba, Ltd. in the registry; they are listed on the company page.