Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000179416

FEI Number

3002468384

Entity Name

TIANJIN MEDICINES & HEALTH PRODUCTS IMP. & EXP. CORP.

City/State/Country

Tianjin, CN

Establishment Address

6 Tangshan Road, Tianjin 300040, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Tianjin Medicines & Health Products Imp. & Exp. Corp. (Owner Number: 10035880)

Owner / Operator Contact Address

6 Tangshan Road, Tianjin, CN-TJ 300040, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

UNIT, OPERATIVE DENTAL, ACCESSORIES EVACUATOR, ORAL CAVITY MOUTHPIECE, SALIVA EJECTORS, PLASTIC TUBES Non-Woven Isolation Gowns & Accessories, Non-Surgical Isolation Gowns MATERIAL, IMPRESSION TRAY, RESIN Barrier Films, Plastic Covers, Plastic Bags TRAY, SURGICAL, INSTRUMENT MIRROR, MOUTH UNIT, SYRINGE, AIR AND/OR WATER MOUTHPIECE, SALIVA EJECTOR Plastic Injectors GAUGE/SPONGE, NONRESORBABLE FOR EXTERNAL USE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2012-05-09
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2012-05-09
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2011-03-29
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2014-05-14
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2012-05-09
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2016-07-20
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-05-09
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2012-05-09
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2012-05-09
HRW	Dynamometer, Nonpowered	Orthopedic	Class 1	888.1250	2012-05-09
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2012-05-09
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2012-05-09

Official Correspondent

Da Qiang Song

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Tianjin Medicines & Health Products Imp. & Exp. Corp.

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
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US
3008813313	RITTER CONCEPT GMBH	Biberach Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000179416. Last updated year: 2026. Please use registration number 1000179416 when referencing this establishment in official correspondence.