Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617438

FEI Number

1000268442

Entity Name

POLYCORE OPTICAL (M) SDN BHD

City/State/Country

SENAI Johor, MY

Establishment Address

LOT PLO 23, KAWASAN, PERINDUSTRIAN SENAI, SENAI Johor 81400, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

POLYCORE OPTICAL (M) SDN BHD (Owner Number: 9035669)

Owner / Operator Contact Address

LOT PLO 23, KAWASAN, PERINDUSTRIAN SENAI, SENAI, MY-01 81400, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

POLYCORE LENSES

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	1998-11-20

Official Correspondent

SIANG MIANG NG

US Agent Details

Wright Lisa Business: THE VISION COUNCIL Email: fda@thevisioncouncil.org Phone: (703) 5484560

Related Public Records

Same Entity

POLYCORE OPTICAL (M) SDN BHD

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3006755718	DONGGUAN YUEHENG OPTICAL CO. LTD.	Dongguan Guangdong, CN
3015534032	BOLLE SAFETY INC	Carlsbad, CA, US
3007675955	Carl Zeiss Vision Canada, Inc.	Toronto Ontario, CA
1000428458	GKB OPHTHALMICS LIMITED - UNIT II	North Goa Goa, IN
3038136215	MEIVISION (VIETNAM) CO., LTD	Ho Chi Minh City, VN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617438. Last updated year: 2026. Please use registration number 9617438 when referencing this establishment in official correspondence.