JINGXIN GROUP (M) SDN BHD

FDA Device Registration & Listing · Kulai Johor, MY · Registration 3033511100

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3033511100
FEI Number
3033511100
Entity Name
JINGXIN GROUP (M) SDN BHD
City/State/Country
Kulai Johor, MY
Establishment Address
No.60, Jalan i-Park 1/5, Kawasan Perindustrian i-Park, Bandar Indahpura, Kulai Johor 81000, MY
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Jingxin Group (M) Sdn Bhd (Owner Number: 10091885)
Owner / Operator Contact Address
No.60, Jalan i-Park 1/5, Kawasan Perindustrian i-Park, Bandar Indahpura, Kulai, MY-01 81000, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

PE GOWN Surgical Gown sanitary napkin Face Mask Caps Isolation Gown

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FYE Dress, Surgical General, Plastic Surgery Class 1 878.4040 2024-11-12
HHD Pad, Menstrual, Unscented Obstetrics/Gynecology Class 1 884.5435 2024-11-12
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2024-11-12
FYF Cap, Surgical General, Plastic Surgery Class 1 878.4040 2024-11-12
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2024-11-12

Official Correspondent

Tao Chen

US Agent Details

Creekon Yang Business: SPICA MEDTECH CORP Email: fda.agent@spicagloble.com Phone: (720) 6176666

Related Public Records

Same Entity

Jingxin Group (M) Sdn Bhd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3039282838 JINGXIN GROUP (M) SDN BHD Kulai Johor, MY

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K823241 Kimberly-Clark Corp. NEW FREEDOM THIN UNSCENTED MAXI PADS 1982-12-28

Similar Registrations

Registration Number Establishment Name Location
1319130 Crosstex International Rush, NY, US
3003965134 RECE INTERNATIONAL CORP. Miami Lakes, FL, US
3010864832 3D DENTAL DESINGS AND DEVELOPMENT Shaker Heights, OH, US
3005012805 MIDWEST STERILIZATION CORP. LAREDO, TX, US
3013269506 TWO ONE TWO NEW YORK, INC. Edgewood, NY, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033511100. Last updated year: 2026. Please use registration number 3033511100 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.