LABCHEM SDN. BHD

FDA Device Registration & Listing · PETALNG JAYA Selangor, MY · Registration 3024860669

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
3024860669
FEI Number
3024860669
Entity Name
LABCHEM SDN. BHD
City/State/Country
PETALNG JAYA Selangor, MY
Establishment Address
NO. 22, JALAN SS 20/10, DAMANSARA KIM,, PETALNG JAYA Selangor 47400, MY
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
LABCHEM SDN. BHD (Owner Number: 10093285)
Owner / Operator Contact Address
NO. 22, JALAN SS 20/10, DAMANSARA KIM,, PETALNG JAYA, MY-10 47400, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

TONGUE DEPRESSOR NON-STERILE; TONGUE DEPRESSOR STERILE APPLICATOR, ENT Applicator, absorbent tipped, sterile APPLICATOR, ABSORBENT TIPPED, NON-STERILE SPOON, OPHTHALMIC Brush, biopsy, general & plastic surgery

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FMA Depressor, Tongue, Non-Surgical General Hospital Class 1 880.6230 2025-04-24
KCJ Applicator, Ent Ear, Nose, Throat Class 1 874.5220 2025-04-24
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2025-04-24
KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital Class 1 880.6025 2025-04-24
HNB Spoon, Ophthalmic Ophthalmic Class 1 886.4350 2025-04-24
GEE Brush, Biopsy, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-04-24

Official Correspondent

Dan Xu

US Agent Details

Kai Li Email: likai323@hotmail.com Phone: (501) 7778490

Related Public Records

Same Entity

LABCHEM SDN. BHD
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 3024860669. Last updated year: 2026. Please use registration number 3024860669 when referencing this establishment in official correspondence.
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