Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016789487

FEI Number

3016789487

Entity Name

JIANGSU CHANGMEI MEDTECH CO.,LTD

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

No.27, Xinke West Road, Luoyang Town, Wujin District, Changzhou Jiangsu 213104, CN

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Jiangsu Changmei Medtech Co.,Ltd (Owner Number: 10065161)

Owner / Operator Contact Address

No.27, Xinke West Road, Luoyang Town, Wujin District, Changzhou, CN-JS 213104, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Kyphoplasty Tool Kit Disposable Endoscopic Hose-type Biopsy Forceps Dilation Balloon Catheter Kyphoplasty Balloon Catheter Kyphoplasty Tool Kit Balloon Inflator Kyphoplasty Tool Kit Kyphoplasty Tool Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OCJ	Spinal Channeling Instrument, Vertebroplasty	Orthopedic	Class 1	888.4540	2024-02-21
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2024-07-17
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2024-07-18
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2023-08-17
HXG	Tamp	Orthopedic	Class 1	888.4540	2023-08-17
OAR	Injector, Vertebroplasty (Does Not Contain Cement)	Orthopedic	Class 1	888.4200	2024-02-21
HXG	Tamp	Orthopedic	Class 1	888.4540	2024-07-18
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2024-02-21
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2024-02-21

Official Correspondent

Yufang Shen

US Agent Details

Jessie Yao Business: MEDRIGHT TECH INC Email: info@medright-tech.com Phone: (718) 2169957

Related Public Records

Same Entity

Jiangsu Changmei Medtech 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
K990935	Pilling Weck Surgical	JACKSON ESOPHAGEAL DILATOR	1999-05-17
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

Similar Registrations

Registration Number	Establishment Name	Location
3008583793	ZAVATION	Flowood, MS, US
3013846070	GREENS SURGICALS PRIVATE LIMITED	Vadodara Gujarat, IN
3027518990	NINGBO HICREN BIOTECHNOLOGY CO., LTD.	Ningbo Zhejiang, CN
1220477	ISOMEDIX OPERATIONS INC.	Northborough, MA, US
2648666	STRYKER PUERTO RICO, LLC.	ARROYO, PR, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016789487. Last updated year: 2026. Please use registration number 3016789487 when referencing this establishment in official correspondence.