Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017181032

FEI Number

3017181032

Entity Name

HARALD AI OY

City/State/Country

Espoo Etela-Karjala, FI

Establishment Address

Tekniikantie 12, Espoo Etela-Karjala 02150, FI

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Harald AI Oy (Owner Number: 10076457)

Owner / Operator Contact Address

Tekniikantie 12, Espoo, FI-02 02150, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Happy Bob

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PJT	Continuous Glucose Monitor Secondary Display	Clinical Chemistry	Class 2	862.1350	2020-07-20

Official Correspondent

Jutta Haaramo

US Agent Details

Maria Makela Makela Business: FinntecPartners, LLC Email: maria.makela@finntecpartners.com Phone: (201) 2944211

Related Public Records

Same Entity

Harald AI Oy

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
2032227	MEDTRONIC MINIMED	NORTHRIDGE, CA, US
3009862700	Senseonics, Inc.	Germantown, MD, US
3028013069	ATULO PRODUCTS	Newton, MA, US
2134850	INTRICON CORPORATION	ARDEN HILLS, MN, US
3007981285	TANDEM DIABETES CARE, INC.	San Diego, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017181032. Last updated year: 2026. Please use registration number 3017181032 when referencing this establishment in official correspondence.