Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017751928

FEI Number

3017751928

Entity Name

DONGGUAN JUNHAI MEDICAL DEVICE CO., LTD

City/State/Country

Dong Guang City Guangdong, CN

Establishment Address

Room 304, Building 1, No. 86, Jinshan Road, Chashan Town, Dong Guang City Guangdong 523391, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DongGuan JunHai Medical Device Co., Ltd (Owner Number: 10081815)

Owner / Operator Contact Address

177 Jin Yang Road, Zhang Yang Area, Zhang Mu Tou Town, Dong Guang City, CN-GD 5236, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Oral Cavity Evacuator Barium Enema Kit Ortho Wax Non-sterile Absorbent Tipped Applicator Suction Handle Dental Floss / Pick Connector (Extension) Manual Toothbrush

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2021-05-18
FCD	Barium Enema Kit	Gastroenterology, Urology	Class 1	876.5210	2021-05-18
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2024-09-25
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2021-05-18
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2021-05-18
JES	Floss, Dental	Dental	Class 1	872.6390	2023-04-26
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2021-05-18
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2021-05-18

Official Correspondent

Rosanne Farrar

US Agent Details

Bryan Tapocik Business: Innovative Product Brands, Inc. Email: bryan@ipbinc.com Phone: (909) 8647477

Related Public Records

Same Entity

DongGuan JunHai Medical Device Co., Ltd

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
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

Similar Registrations

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3015703934	MEDFRUITION ELECTRONICS TECHNOLOGY CO., LTD	Foshan City Guangdong, CN
3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US
3010162973	Synergy Health Marseille SAS	MARSEILLE CEDEX 14 Provence-Alpes-Cote d'Azur, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017751928. Last updated year: 2026. Please use registration number 3017751928 when referencing this establishment in official correspondence.