Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042191618

FEI Number

3042191618

Entity Name

SMP MEDTECH SDN. BHD.

City/State/Country

Nilai Negeri Sembilan, MY

Establishment Address

No.81,Jalan Platinum 5/6,XME Business Park, Nilai Negeri Sembilan 71800, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SMP MEDTECH SDN. BHD. (Owner Number: 10094077)

Owner / Operator Contact Address

No.81,Jalan Platinum 5/6,XME Business Park, Nilai, MY-05 71800, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

self-sealing sterilization pouch Sterilization Pouches and Reels

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2025-11-17
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2025-10-28
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2025-10-28

Official Correspondent

YIQIN SONG

US Agent Details

Troy Metcalf Email: Info@Tcdentalmedicalsupplies.com Phone: (714) 6327499

Related Public Records

Same Entity

SMP MEDTECH SDN. BHD.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042191618. Last updated year: 2026. Please use registration number 3042191618 when referencing this establishment in official correspondence.