Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006536571

FEI Number

3006536571

Entity Name

SHUMEI INDUSTRIAL (HEBEI) CO., LTD.

City/State/Country

CHANG ZHOU CITY Hebei, CN

Establishment Address

CHEN ZHUANG TOWN, XIAN COUNTY, CHANG ZHOU CITY Hebei --, CN

Establishment Type(s)

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

Owner / Operator

Shummi Enterprise Co, Ltd (Owner Number: 9007361)

Owner / Operator Contact Address

13F-1 No. 188 Nanking Road Section 5, Taipei 105, TW-TPE 105, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DENTAL WAX MOUTH DENTAL MANUAL TOOTHBRUSH Pre-pasted toothbrush Comfort Picks Explorer Dental Floss Applicator, Butt Brush POWERED DENTAL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2007-03-22
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2007-03-06
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2007-03-06
JET	Pick, Massaging	Dental	Class 1	872.6650	2017-08-08
EKB	Explorer, Operative	Dental	Class 1	872.4565	2011-01-26
JES	Floss, Dental	Dental	Class 1	872.6390	2007-03-06
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2022-08-02
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2007-03-06

Official Correspondent

No official correspondent registered.

US Agent Details

A.W. Gebhard Business: LUCKY CHIN INC. Email: luckychin@att.net Phone: (303) 7771819

Related Public Records

Same Entity

Shummi Enterprise Co, Ltd

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005816808	Shummi Enterprise Co., Ltd.	Taipei, TW

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10

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1821514	KULZER, LLC	SOUTH BEND, IN, US
3004623350	ASHTEL STUDIOS, INC.	Ontario, CA, US
3022519816	SHENZHEN YONGCHANGHE TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006536571. Last updated year: 2026. Please use registration number 3006536571 when referencing this establishment in official correspondence.