Data / Medical devices / Japan / Biolis Medical Corp.
Biolis Medical Corp.: FDA-registered device maker in Hino Tokyo, Japan, 2 510(k) clearances
Biolis Medical Corp. is registered with the FDA (registration 3004378326) in Hino Tokyo, Japan. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 1, 2011. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3004378326
- Address
- 1-14-21 Higashitoyoda, Hino Tokyo, Japan, 191-0052
- Owner or operator
- Biolis Medical Corp. (9060135)
- Roles
- Manufacturer
- First device listed
- December 9, 2003
- Registered through
- 2026
- Brand names listed
- BIOLIS 30i, Calibrator 1, Calibrator 2, Calibrator Set A, B, Cl (Chloride) Electrode, DZ-Lite c270, Dialysis Calibrator, IMMTOX 270 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Manufacturer | accessdata.fda.gov |
| Calibrator, Multi-Analyte Mixture | JIX | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Ion Specific, Potassium | CEM | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Ion Specific, Sodium | JGS | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Ion-Specific, Chloride | CGZ | 2 | Manufacturer | accessdata.fda.gov |
| Hexokinase, Glucose | CFR | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 1, 2011 | K103531 | PRESTIGE 24I; BIOLIS 24I; MGC 240 | CFR | Substantially Equivalent | Tokyo Boeki Medisys, Inc. | accessdata.fda.gov |
| February 15, 2005 | K040958 | PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 | JJE | Substantially Equivalent | Tokyo Boeki Medical System , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- All makers of Hexokinase, Glucose
- All makers of Electrode, Ion Specific, Potassium
- All makers of Calibrator, Multi-Analyte Mixture
- All makers of Electrode, Ion Specific, Sodium
- All makers of Electrode, Ion-Specific, Chloride
Updated December 1, 2011. 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.