Data / Medical devices / Finland / Aidian OY
Aidian OY: FDA-registered device maker in ESPOO Uusimaa, Finland, 2 510(k) clearances
Aidian OY is registered with the FDA (registration 9610102) in ESPOO Uusimaa, Finland. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 10, 2016. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9610102
- FEI number
- 3002807786
- Address
- Koivu-Mankkaan Tie 6B, ESPOO Uusimaa, Finland, 02200
- Owner or operator
- AIDIAN OY (9062384)
- Roles
- Manufacturer
- First device listed
- December 14, 2005
- Registered through
- 2026
- Brand names listed
- QuikRead go CRP, QuikRead go CRP Control Set, QuikRead go CRP Verification Set, QuikRead go Instrument, UniQ PINP RIA, Uricult CLED+Polymyxin/EMB, Uricult CLED+Polymyxin/MacConkey, Uricult CLED/EMB and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | 2 | Manufacturer | accessdata.fda.gov |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | 1 | Manufacturer | accessdata.fda.gov |
| Culture Media, Non-Selective And Differential | JSH | 1 | Manufacturer | accessdata.fda.gov |
| Culture Media, Selective And Differential | JSI | 1 | Manufacturer | accessdata.fda.gov |
| Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | CIN | 2 | Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | 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 |
|---|---|---|---|---|---|---|
| March 10, 2016 | K142993 | QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument | DCK | Substantially Equivalent | Orion Diagnostica, OY | accessdata.fda.gov |
| May 4, 2005 | K043125 | ORION DIAGNOSTICA UNIQ PINP RIA | CIN | Substantially Equivalent | Orion Diagnostica, OY | accessdata.fda.gov |
Compare with other makers
- All makers of Culture Media, Selective And Differential
- All makers of C-Reactive Protein, Antigen, Antiserum, And Control
- All makers of Colorimeter, Photometer, Spectrophotometer For Clinical Use
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
- All makers of Culture Media, Non-Selective And Differential
Updated March 10, 2016. 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.