Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015599655

FEI Number

3015599655

Entity Name

OURA HEALTH OY

City/State/Country

Oulu Pohjois-Pohjanmaa, FI

Establishment Address

Elektroniikkatie 10, Oulu Pohjois-Pohjanmaa 90590, FI

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Oura Health Oy (Owner Number: 10088524)

Owner / Operator Contact Address

Elektroniikkatie 10, Oulu, FI-NOTA 90590, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Fertile Window

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LHD	Device, Fertility Diagnostic, Proceptive	Unknown	Class U	N/A	2023-08-08

Official Correspondent

Michael Righter

US Agent Details

Michael Righter Email: michael.righter@ouraring.com Phone: (415) 7873295

Related Public Records

Same Entity

Oura Health 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 3015599655. Last updated year: 2026. Please use registration number 3015599655 when referencing this establishment in official correspondence.