Data / Medical devices / Micro Total Analysis Instrument System
Micro Total Analysis Instrument System (OUE): 3 FDA-registered makers in 1 country
3 establishments in 1 country are registered with the FDA to make Micro Total Analysis Instrument System (product code OUE, Class 2, 21 CFR 862.2570). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OUE
- Device class
- 2
- Regulation
- 862.2570
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| Japan | 3 |
Makers of Micro Total Analysis Instrument System
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| FUJIFILM Healthcare Manufacturing Corporation MIE Office | Komono-cho, Mie-gun, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office | MINAMIASHIGARA-SHI Kanagawa, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki) | Amagasaki-shi Hyogo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.