Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008819648

FEI Number

3008819648

Entity Name

F.R.GALANTAI MANUFACTURING COMPANY LIMITED

City/State/Country

Auckland, NZ

Establishment Address

11 Bancroft Crescent, Auckland 0602, NZ

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

F.R.GALANTAI MANUFACTURING COMPANY LIMITED (Owner Number: 10053212)

Owner / Operator Contact Address

11 Bancroft Crescent, Auckland, NZ-AUK 0602, NZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Stubby Brush The PULL THRU Cleaning Brush

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2016-12-01

Official Correspondent

Rod Galantai

US Agent Details

Diane Horwitz Business: Mandell Horwitz Consultants LLC Email: dmh@mandellhorwitzconsulting.com Phone: (703) 3072921

Related Public Records

Same Entity

F.R.GALANTAI MANUFACTURING COMPANY LIMITED

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 3008819648. Last updated year: 2026. Please use registration number 3008819648 when referencing this establishment in official correspondence.