Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004123648

FEI Number

3004123648

Entity Name

HEXAMER OY

City/State/Country

Turku Pirkanmaa, FI

Establishment Address

Pakurlantie 6, Turku Pirkanmaa 20380, FI

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hexamer Oy (Owner Number: 10060639)

Owner / Operator Contact Address

Pakurlantie 6, Ilmarinen, FI-19 21350, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HHE	Cup, Menstrual	Obstetrics/Gynecology	Class 2	884.5400	2019-06-05

Official Correspondent

Toni Intonen

US Agent Details

Richard Ulfvengren Business: Lunette US Inc. Email: richard@lunette.com Phone: (310) 9185875

Related Public Records

Same Entity

Hexamer 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 3004123648. Last updated year: 2026. Please use registration number 3004123648 when referencing this establishment in official correspondence.