Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016248661

FEI Number

3016248661

Entity Name

MINZE NV

City/State/Country

Antwerpen, BE

Establishment Address

Lange Gasthuisstraat 29, bus 15, Antwerpen 2000, BE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Minze NV (Owner Number: 10085143)

Owner / Operator Contact Address

Lange Gasthuisstraat 29, bus 15, Antwerpen, BE-VAN 2000, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Minze Uroflow Minze Uroflow Accessories Minze Diary Minze Platform

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EXY	Uroflowmeter	Gastroenterology, Urology	Class 2	876.1800	2022-05-11

Official Correspondent

Josef Sageder

US Agent Details

Naiara Otero Business: Minze Health Inc Email: naiara.otero@minzehealth.com Phone: (888) 4212793

Related Public Records

Same Entity

Minze NV

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 3016248661. Last updated year: 2026. Please use registration number 3016248661 when referencing this establishment in official correspondence.