Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043535416

FEI Number

3043535416

Entity Name

Pak Mane Brush (Malaysia) Sdn. Bhd.

City/State/Country

Pasir Gudang Johor, MY

Establishment Address

No.12,Jalan Ekoperniagaan 4, Taman Kota Masai, Pasir Gudang Johor 81700, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Pak Mane Brush Limited (Owner Number: 10043952)

Owner / Operator Contact Address

Flat C, 14/F, Blk 4, Golden Dragon Ind. Centre, 182-190 Tai Lin Pai Road,Kwai Chung, N.T., Hong Kong, HK-NOTA 999077, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2013-04-10

Official Correspondent

No official correspondent registered.

US Agent Details

Li Wang Business: Dr. Brown's Company Email: li.wang@drbrownsbaby.com Phone: (314) 4453357

Related Public Records

Same Entity

Pak Mane Brush Limited

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012499628	Pak Mane Plastic And Metal (Shen Zhen) Company Limited	Shenzhen Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

Similar Registrations

Registration Number	Establishment Name	Location
3006149964	POWERLINK CREATIONS (ZHONGSHAN) CORPORATION	Zhongshan Guangdong, CN
3002762071	EBNAT AG	Ebnat-Kappel Sankt Gallen, CH
3026482909	WALDKRAFT GMBH	Todtnau Baden-Wurttemberg, DE
3015913483	GRAND S KOREA CO., LTD.	Goyang-si Gyeonggi, KR
3043840120	CURIDENT, LLC	Boca Raton, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043535416. Last updated year: 2026. Please use registration number 3043535416 when referencing this establishment in official correspondence.