Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004096300

FEI Number

3004096300

Entity Name

Cixi Qimei Combination Tool Packing Factory

City/State/Country

Cixi City Shanghai, CN

Establishment Address

Yin Hai Chun, Chang He Town, Cixi City, Zhe Jiang Province, Cixi City Shanghai 315326, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Cixi Qimei Combination Tool Packing Factory (Owner Number: 10023543)

Owner / Operator Contact Address

Yin Hai Chun, Chang He Town, Cixi City, Zhe Jiang Province, Cixi City, CN-SH 315326, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Barium enema kit FLOSS, DENTAL PICK, MASSAGING Impression Trays SCALER, PERIODONTIC F Connector Suction Handle Suction Handle Mouth Mirror

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FCD	Barium Enema Kit	Gastroenterology, Urology	Class 1	876.5210	2013-10-31
JES	Floss, Dental	Dental	Class 1	872.6390	2008-12-24
JET	Pick, Massaging	Dental	Class 1	872.6650	2011-01-18
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2022-03-28
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2011-01-18
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2014-03-05
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2013-12-12
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2022-03-31
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2011-01-18

Official Correspondent

No official correspondent registered.

US Agent Details

Bryan Tapocik Business: IPB Inc Email: yesenia@ipbinc.com Phone: (909) 8647477

Related Public Records

Same Entity

Cixi Qimei Combination Tool Packing Factory

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Similar Registrations

Registration Number	Establishment Name	Location
3017751928	DONGGUAN JUNHAI MEDICAL DEVICE CO., LTD	Dong Guang City Guangdong, CN
3016396121	CONVII INC	Santa Clara, CA, US
3007420842	Hebei Fenghe Biotechnology INC.,Ltd	Handan Hebei, CN
1000508490	AGRITALIA SPA	ISOLA E2 Napoli, IT
3033258462	ANQING GEHENG E-COMMERCE CO., LTD.	Anqing Anhui, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004096300. Last updated year: 2026. Please use registration number 3004096300 when referencing this establishment in official correspondence.