Topcon Healthcare Solutions EMEA Oy

FDA Device Registration & Listing · OULU Pohjois-Pohjanmaa, FI · Registration 3014926240

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014926240
FEI Number
3014926240
Entity Name
Topcon Healthcare Solutions EMEA Oy
City/State/Country
OULU Pohjois-Pohjanmaa, FI
Establishment Address
Saaristonkatu 9, OULU Pohjois-Pohjanmaa 90100, FI
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Topcon Healthcare Solutions EMEA Oy (Owner Number: 10058704)
Owner / Operator Contact Address
Saaristonkatu 9, OULU, FI-NOTA 90100, FI
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

RDx Harmony Plus Harmony Referral System Optoflow Harmony One RDx

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OUG Medical Device Data System General Hospital Class 1 880.6310 2018-10-22
HKO Refractometer, Ophthalmic Ophthalmic Class 1 886.1760 2026-03-24

Official Correspondent

No official correspondent registered.

US Agent Details

Susan Quick Business: Topcon Healthcare, Inc. Email: tmsregulatory@topcon.com Phone: (216) 7805532

Related Public Records

Same Entity

Topcon Healthcare Solutions EMEA Oy
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014926240. Last updated year: 2026. Please use registration number 3014926240 when referencing this establishment in official correspondence.
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