Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011252788

FEI Number

3011252788

Entity Name

Changzhou Rongxin Medicine Minimal Invasion Technology Co., Ltd

City/State/Country

Jintan Jiangsu, CN

Establishment Address

No. 8, Jianerkang Road, IndustrialConcentration Area,Zhixi Town, Jintan Jiangsu 213200, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Changzhou Rongxin Medicine Minimal Invasion Tech. Co., Ltd. (Owner Number: 10047661)

Owner / Operator Contact Address

No. 8, Jianerkang Road, IndustrialConcentration Area,Zhixi Town, Jintan, CN-JS 213200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Connecting tube TUBE, ASPIRATING, FLEXIBLE, CONNECTING CATHETER, RETENTION TYPE, BALLOON SPOON, EAR CONTAINER, SPECIMEN, NON- STERILE STYLET, TRACHEAL TUBE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2018-12-18
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2018-12-25
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2018-06-04
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2014-10-16
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2024-04-24
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2019-10-21

Official Correspondent

Rui Pan

US Agent Details

Cancan Huang Business: Osmunda Technology Co., Ltd. Email: Sunny.Huang@Osmundacn.Com Phone: (858) 3571157

Related Public Records

Same Entity

Changzhou Rongxin Medicine Minimal Invasion Tech. 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
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08
K233013	Silq Technologies Corporation	2-Way 100% Silicone Cleartract Catheter	2024-01-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.

Similar Registrations

Registration Number	Establishment Name	Location
2953726	ADDITION TECHNOLOGY, INC.	Lombard, IL, US
3043534762	AVANTTI MEDI CLEAR MBP, S.A.P.I. DE C.V.	TIJUANA Baja California, MX
2320762	DEROYAL INDUSTRIES, INC.	NEW TAZEWELL, TN, US
3031231776	Perfect Ophthalmic Instruments FZE	Dubai Dubayy, AE
3004839227	Cardinal Health Malta 212 Ltd	Marsa, MT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011252788. Last updated year: 2026. Please use registration number 3011252788 when referencing this establishment in official correspondence.