Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038613785

FEI Number

3038613785

Entity Name

J&Y SAFETY (M) SDN. BHD.

City/State/Country

SHAH ALAM Selangor, MY

Establishment Address

No. 3 Jalan Modal 23/2, Kawasan Perindustrian Miel Seksyen 23, SHAH ALAM Selangor 40300, MY

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

J&Y SAFETY (M) SDN. BHD. (Owner Number: 10093484)

Owner / Operator Contact Address

No. 3 Jalan Modal 23/2, Kawasan Perindustrian Miel Seksyen 23, SHAH ALAM, MY-10 40300, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

accessory, surgical apparel Sporting Glasses Protection Glasses Protection Goggle mask, scavenging lens, spectacle, non-custom (prescription) protector, hearing (circumaural) protector, hearing (insert)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2025-05-22
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2025-08-26
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2025-05-22
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2025-05-22
EWE	Protector, Hearing (Circumaural)	Unknown	Class U	N/A	2025-05-22
EWD	Protector, Hearing (Insert)	Unknown	Class U	N/A	2025-05-22

Official Correspondent

Ken Luo

US Agent Details

Yueting Zhu Business: SOUTH BAY INNOVATION LLC Email: southbayinnovation@southbayinnovation.com Phone: (424) 3769142

Related Public Records

Same Entity

J&Y SAFETY (M) SDN. BHD.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
9680454	EMPRESAS IAI S DE RL DE C.V.	H. MATAMOROS Tamaulipas, MX
3010227982	Tianjin Zhengtian Medical Instrument Co., Ltd.	Tianjin, CN
3016871880	PRIMEX DESIGN & FABRICATION	Richmond, IN, US
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038613785. Last updated year: 2026. Please use registration number 3038613785 when referencing this establishment in official correspondence.