Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017970306

FEI Number

3017970306

Entity Name

THERMIDAS OY

City/State/Country

TAMPERE Pirkanmaa, FI

Establishment Address

Polttimonkatu 4, TAMPERE Pirkanmaa 33210, FI

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TherMidas Oy (Owner Number: 10080202)

Owner / Operator Contact Address

Polttimonkatu 4, TAMPERE, FI-11 33210, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200999

PMA Number

N/A

All Registered Proprietary Names

Thermidas IR System (ThIR-A615) Thermidas Remote SW (ThRemote) Thermidas IRT-384 Tablet (ThIRT-384) Thermidas VistaClinic Analyzer (ThAnalyzer)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LHQ	System, Telethermographic (Adjunctive Use)	Obstetrics/Gynecology	Class 1	884.2980	2021-01-25

Official Correspondent

Juha Hamalainen

US Agent Details

Juha Hamalainen Business: Thermidas Americas, INC. Email: juha.hamalainen@thermidas.fi Phone: (404) 9938963

Related Public Records

Same Entity

TherMidas 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 3017970306. Last updated year: 2026. Please use registration number 3017970306 when referencing this establishment in official correspondence.