Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016994953

FEI Number

3016994953

Entity Name

CHANGZHOU 3R MEDICAL DEVICE TECHNOLOGY CO., LTD.

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

19# Building 1st and 2nd Floor No.47 Qingyang North Road Tianning District, Changzhou Jiangsu 213017, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Changzhou 3R Medical Device Technology Co., Ltd. (Owner Number: 10068123)

Owner / Operator Contact Address

19# Building 1st and 2nd Floor No.47 Qingyang North Road Tianning District, Changzhou, CN-JS 213017, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

STAPLE, REMOVABLE (SKIN) FORCEPS, BIOPSY, NON-ELECTRIC DRESS, SURGICAL Face Mask Within the Scope of the Face Mask and Barrier Face Covering Enforcement Policy or Face Mask Umbrella EUA Stapler Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) Applier, staple, surgical, COVER, SHOE, OPERATING-ROOM Non-surgical gown CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2023-02-21
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2023-02-21
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-04-08
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-04-08
QQS	Stapler, Skin	General Hospital	Class 1	878.4740	2026-03-10
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-04-08
GEF	Applier, Staple, Surgical,	General, Plastic Surgery	Class 1	878.4800	2024-12-21
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-04-08
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-04-08
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2023-02-21
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2023-02-21

Official Correspondent

runting Tian

US Agent Details

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

Related Public Records

Same Entity

Changzhou 3R Medical Device 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
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

Similar Registrations

Registration Number	Establishment Name	Location
3032747418	HEXAMED PVT LTD	Sialkot Punjab, PK
1000175697	HARITEX CORPORATION	TAIPEI CITY, TW
1043214	DEROYAL INDUSTRIES, INC.	POWELL, TN, US
3006210673	ZHEJIANG MEDIUNION HEALTHCARE GROUP CO.,LTD	Ningbo Zhejiang, CN
3011137372	Teleflex Medical LLC	Morrisville, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016994953. Last updated year: 2026. Please use registration number 3016994953 when referencing this establishment in official correspondence.