Data / Medical devices / Finland / Topcon Healthcare Solutions EMEA Oy
Topcon Healthcare Solutions EMEA Oy: FDA-registered device maker in OULU Pohjois-Pohjanmaa, Finland, 1 510(k) clearance
Topcon Healthcare Solutions EMEA Oy is registered with the FDA (registration 3014926240) in OULU Pohjois-Pohjanmaa, Finland. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 13, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014926240
- Address
- Saaristonkatu 9, OULU Pohjois-Pohjanmaa, Finland, 90100
- Owner or operator
- Topcon Healthcare Solutions EMEA Oy (10058704)
- Roles
- Manufacturer
- First device listed
- October 22, 2018
- Registered through
- 2026
- Brand names listed
- Harmony One, Harmony Plus, Harmony Referral System, Optoflow, RDx
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Refractor, Manual, Non-Powered, Including Phoropter | HKN | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Management, Ophthalmic | NFJ | 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 |
|---|---|---|---|---|---|---|
| September 13, 2021 | K210396 | Harmony Referral System | NFJ | Substantially Equivalent | Topcon Healthcare Solutions EMEA Oy | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Management, Ophthalmic
- All makers of Medical Device Data System
- All makers of Refractor, Manual, Non-Powered, Including Phoropter
Updated September 13, 2021. 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.