Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005739529

FEI Number

3005739529

Entity Name

Zhejiang Gongdong Medical Technology Co., Ltd

City/State/Country

TAIZHOU Zhejiang, CN

Establishment Address

a)No 10 & 39 ,Beiyuan Ave., b)No.88 Jingxian Rd. Huangyan, TAIZHOU Zhejiang 318020, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. (Owner Number: 9072045)

Owner / Operator Contact Address

BEICHENG INDUSTRIAL AREA, HUANGYAN, TAIZHOU, CN-ZJ 318020, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GONGDONG TRANSFER PIPETTE Capilary blood collection tube with clot activator and Gel;Capilary blood collection tube with EDTAK2; Capilary Blood Collection Tubes 9NC Coagulation Sodium Citrate 3.8% Capilary blood collection tube with EDTAK3;Capilary blood collection tube with Lithium heparin; Capilary blood collection tube with clot activator;Capilary blood collection tube no activator; Capilary Blood Collection Tubes 9NC Coagulation Sodium Citrate 3.2%; Capilary blood collection tube with Sodium heparin;Capilary blood collection tube with sodium fluoride/sodium heparin; Capilary blood collection tube with sodium fluoride/potassium oxalate GONGDONG CUVETTE Disposable Otoscope Specula Cover, 2.5mm, Pediatric Disposable Otoscope Specula Cover, 4.25mm, Adult Tongue Depressor DISPENSER, LIQUID MEDICATION Latex-Free Tourniquet, Surgical tape Placenta basin Sharp Container,Needle collector Viral Transport Media Kit Urine Clean Catch Collection Set & Tube Sterile Blood Culture Diversion Tube, No Activator GDC-03-F, GDC-03-X, GDC-05-F, GDC-05-X, GDC-07-F, GDC-07-X, GDC-13-X,SC-01Q, SC-02Q, SC-05Q, SC-01G, SC-02G, SC-06 Sharp Container,Needle collector MULTIPLE &ACCESSORIES Disposable Face shield PPLICATOR, ABSORBENT TIPPED non-sterile, sampling swab kit Non-Sterile GONGDONG DISPOSABL VAGINAL SPECULUM Absorbent tipped applicator; Sampling Swab APPLICATOR, ABSORBENT TIPPED sterile, sampling swab kit Sterile, Placenta basin Saliva Collection Kit Vacuum specimen collection tube NO ADDIT; Plastic Conical Bottom Tube with Preservative for Urinalysis; Plastic Round Bottom Tube with Preservative for Urinalysis; FLUID COLLECTION BAG Transport tube Cryogenic Vial Sterile Urine Specimen Containers w/ needle cap Sterile Urine Specimen Containers with Temperature Strip; Sterile Urine Specimen Containers; Sample collection tubes Vacuum Urine Tube urine container Midstream catch kit Urine Collection Kit (Excludes HIV testing) Disposable Vaginal Speculum BAPA Tube for T-TAS 01 Dispenser, Liquid Medication - Feeding Syringes, Dispensers 20ml Dosage cup Sharp Container,Needle collector Gongdong ALCOHOL PAD Lighted Handle Cover Test tube Gongdong Centrifugation Tube Sample Cup& Specimen container Vacumm Urine tube Saliva Collection Kit,NON Sterile Biohazard Bags Quantisal Expressor (filter frit) with lid and ring Urine Transfer Straw Urine Specimen Collection Kit Specimen Bag Quantisal Expressor (filter frit) without lid Synergy Beaker; Gongdong Vial Collection Containers; Gongdong Vial DOA Kits; Gongdong Vial Transport Containers;

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2007-03-14
GIO	Tube, Collection, Capillary Blood	Hematology	Class 1	864.6150	2010-10-27
JRI	Cuvette, Thermostated	Clinical Chemistry	Class 1	862.2050	2007-03-14
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2016-08-18
FFQ	Speculum, Rectal	Gastroenterology, Urology	Class 1	876.4730	2017-01-23
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2007-10-31
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2023-02-26
BYZ	Trap, Sterile Specimen	General Hospital	Class 2	880.6740	2007-07-18
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2023-08-21
KJC	Bottle, Roller, Tissue Culture	Hematology	Class 1	864.2240	2007-07-18
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2026-06-11
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2011-09-22
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2008-11-28
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	2020-09-09
OIE	Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2026-01-13
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)	Clinical Chemistry	Class 2	862.1675	2023-06-08
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2020-11-17
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2011-09-22
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-05-03
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2020-09-08
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2006-07-20
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2020-03-20
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2026-06-08
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2006-05-15
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2023-02-21
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2010-09-05
JOZ	System, Automated Platelet Aggregation	Hematology	Class 2	864.5700	2020-07-07
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2022-06-15
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2026-01-03
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2021-12-16
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2025-05-15
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2007-03-14
NNL	Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile	Pathology	Class 1	864.3250	2022-05-25

Official Correspondent

Jingxiang Zhang

US Agent Details

Ivy Shi Email: ivy.syb@hotmail.com Phone: (626) 8188776

Related Public Records

Same Entity

ZHEJIANG GONGDONG MEDICAL TECHNOLOGY 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
K834189	Imm Enterprises , Ltd.	JAKOBI SURG. INSTRUMENTS #7 44/47	1984-03-06
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08
K880142	Hardy Media	TSA W/LEC. & TWEEN. 80	1988-03-30
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02

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.

Similar Registrations

Registration Number	Establishment Name	Location
3010127792	Sartorius Liquid Handling Oy	Kajaani, Finland Kainuu, FI
3010683392	JIANGSU KEHUA MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.	Dongtai Jiangsu, CN
3023591031	SEQUITUR HEALTH CORP.	Phoenix, AZ, US
3001856801	RITTER GMBH	Schwabmuenchen Bavaria, DE
1319681	ORTHO-CLINICAL DIAGNOSTICS, INC.	Rochester, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005739529. Last updated year: 2026. Please use registration number 3005739529 when referencing this establishment in official correspondence.