Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010599708

FEI Number

3010599708

Entity Name

EUROLATEX SDN BHD

City/State/Country

Kedah, MY

Establishment Address

Plot 33, Kuala Ketil Industrial Estate, Kuala Ketil, Kedah 09300, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EUROLATEX SDN BHD (Owner Number: 10084503)

Owner / Operator Contact Address

Plot 33, Kuala Ketil Industrial Estate, Kuala Ketil, Kedah,, MY-NOTA 09300, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210208

PMA Number

N/A

All Registered Proprietary Names

Caliber

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2022-03-01

Official Correspondent

Neville Muringayi

US Agent Details

Neville Muringayi Business: Caliber Brand LLC Email: nevillemuringayi@gmail.com Phone: (951) 7466130

Related Public Records

Same Entity

EUROLATEX SDN BHD

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
9611836	Guangzhou Double One Latex Products Co., Ltd.	GUANGZHOU CITY Guangdong, CN
3003370588	IMPORT WAREHOUSE INC	Dallas, TX, US
3006799339	Nulatex Sdn. Bhd.	Kluang Johor, MY
3026885377	SHANGHAI PERSONAGE HYGIENE PRODUCTS CO.,LTD.	Shanghai, CN
9616559	RICHTER RUBBER TECHNOLOGY SDN. BHD.	KUALA KETIL Kedah, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010599708. Last updated year: 2026. Please use registration number 3010599708 when referencing this establishment in official correspondence.