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Sign in to claim this brandOtsuka America Pharmaceutical Inc
US
Last updated May 31, 2026
What Otsuka America Pharmaceutical Inc makes
The company produces diagnostic kits for detecting *Helicobacter pylori* infection via urease activity, including chromogenic test systems for breath analysis. It also manufactures wearable devices that continuously monitor multiple physiological parameters, such as medication adherence and vital signs, using reusable sensors and digital tracking platforms.
These products are regulated under FDA classifications, with diagnostic kits falling under Class II and wearable monitors classified as Class III. They are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries, reflecting their authorised status for commercial distribution in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Otsuka America Pharmaceutical Inc manufacture?
Otsuka America Pharmaceutical Inc produces two primary categories of medical devices: diagnostic kits for detecting *Helicobacter pylori* infection through urease activity, such as chromogenic test systems for breath analysis, and wearable devices that continuously monitor multiple physiological parameters. These include medication adherence trackers and vital sign monitors, often paired with reusable sensors and digital feedback platforms.
Where is Otsuka America Pharmaceutical Inc based, and how does that affect its devices?
The company is based in the United States, which means its medical devices are regulated under FDA guidelines. This regulatory framework ensures that devices like diagnostic kits and wearable monitors meet safety, performance, and compliance standards before being authorised for commercial distribution in the US market.
Which regulatory registries list Otsuka America Pharmaceutical Inc’s devices?
Otsuka America Pharmaceutical Inc’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The 510(k) registry documents premarket submissions for devices deemed substantially equivalent to existing authorised products, while the UDI registry ensures each device has a unique identifier for tracking and traceability in the US market.
How are Otsuka America Pharmaceutical Inc’s devices classified under FDA regulations?
Otsuka America Pharmaceutical Inc’s diagnostic kits, such as those for *Helicobacter pylori* detection, are classified as Class II devices, indicating moderate regulatory control due to their non-invasive nature and well-established safety profiles. In contrast, its wearable physiological monitors (e.g., medication adherence trackers) fall under Class III, requiring stricter premarket approval due to higher risk potential and innovative technologies.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- otsuka-us.com
- —
- —
- [email protected]
- Phone
- 410-353-8778
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 008314390
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA | 1.1 | FDA UDI | Class III | Unknown |
| BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit) | 01M | FDA UDI | Class III | Active |
| Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA | 2.0 | FDA UDI | Class III | Active |
| MyCite Patch | DW5 | FDA UDI | Class II | Unknown |
| BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) | 01 | FDA UDI | Class III | Active |
| MyCite Patch | RW2 | FDA UDI | Class II | Active |
| Rejoyn | K231209 | FDA 510(k) | Class II | Active |
| Otsuka Digital Feedback Device-RW | K223463 | FDA 510(k) | Class II | Active |
| Otsuka Digital Feedback Device | K251088 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Otsuka America Pharmaceutical Inc. has one FDA recall record initiated on January 18, 2008, which is listed with a terminated status. The recall was due to a potential issue with a medical device power supply that may overheat and emit smoke.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 18, 2008 | Z-1749-2008 | — | terminated | Medical device power supply may overheat and cause smoke to be emitted from the device. |