Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014739961

FEI Number

3014739961

Entity Name

JIANGSU ROOE MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Zhangjiagang City Jiangsu, CN

Establishment Address

No. 19, Renmin East Road, Yangshe Town,, Zhangjiagang City Jiangsu 215600, CN

Establishment Type(s)

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

Owner / Operator

Jiangsu Rooe Medical Technology Co., Ltd. (Owner Number: 10091569)

Owner / Operator Contact Address

No. 19, Renmin East Road, Yangshe Town,, Zhangjiagang City, CN-JS 215600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ROOE Medical Electric Hydraulic Operation Table Electric Operation Table, Manual Hydraulic Operation Table, Manual Operation Table, Obstetric Table Blood Bank PH Meter: Biological Safety Cabinet, Laminar Flow Cabinet Ultrasonic Cleaner, Pipette, Microtome, Laboratory Freezer, Analysis Balance, Medical Centrifuge, Shaker, Mixer, Thermostatic Bath, Stirrer, Water Distiller, Laboratory incubator, ROOE Medical Dental Unit, Dental Accessories Anesthesia trolley, ABS cart, dressing trolley; Emergency Trolley, Medical Workstation trolley, Medicine trolley, Patient trolley, transfer trolley Continuous Passive Motion FInger CPM-Finfer; CPM ROOE Medical Electrocardiograph MachineECG Machine, EkG Machine Medical Bed Mattress, Bed Sheet, Bed Cover, Warming Blanket, Air Mattress, Water Mattress, Bedsore Prevention Mattress Disposable Manual Resuscitator; Manual emergency ventilator(Resuscitator); PVC Manual Resuscitator Corpse Transportation Trolley Mortuary Refrigerator, Trash Can; Mortuary Equipment: Corpse; Storage Shelf, Autopsy Table, Body bag, ROOE Medical CPR Aid Device, CPR Training Defibrillator CPR Training AED, CPR Training Manikin, Nurse Training Manikin Cabinet, Table and Tray, Anesthesia ROOE Medical Sterilizer, Autoclave, Steam Sterilizer, Uv Sterilizer, Dry Heat Sterilizer Ophthalmic Table ROOE Medical Dental Chair, Bedside Table; Medical Chair, Dialysis Chair, ENT Chair, Waiting Chair, Infusion Chair, Ophthalmic Chair, Blood Donor Chair, Accompany Chair, Bath Chair, Over-Bed Table, ENT Table, Folding Table, Extremity Kit; Extrication Device; Head Immobilizer; Straps; Traction Leg Splint Stretcher, Hand-Carried ROOE Medical X-Ray System, Radiography XRay System, DR X-Ray System, C-Arm X-Ray System, Mammography X-Ray System Medical Stretcher Wheeled; Stretcher Blood Bank Refrigerator; Car Refrigerator; Combination Freezer; Corpse Refrigerator;Double Door Laboratory Refrigerator; Ultra Low Temperature Freezer; Upright Freezer Mini Laboratory Refrigerator; Portable Refrigerator; Single Door Laboratory Refrigerator; Solar Refrigerator; Washer Of Body Waste Receptacles PATIENT LIFT Mortuary table Electric, Autopsy Table, Examination Table ROOE Medical Monitor, Bed Patient Monitor, Blood Pressure Monitor Fetal Monitor, Baby Monitor TOURNIQUET, PNEUMATIC Patient transfer device, transfer trolley

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2024-10-16
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2024-10-16
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2024-10-16
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2024-10-16
BXB	Exerciser, Powered	Physical Medicine	Class 1	890.5380	2024-10-16
MLN	Electrode, Electrocardiograph, Multi-Function	Cardiovascular	Class 2	870.2360	2024-10-16
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2024-10-16
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2024-10-18
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2026-01-04
PMK	Cpr Aid Device Without Feedback	Cardiovascular	Class 1	870.5210	2024-10-16
BRY	Cabinet, Table And Tray, Anesthesia	Anesthesiology	Class 1	868.6100	2024-10-16
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2024-10-16
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2024-10-16
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2024-10-16
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2024-10-16
JAC	System, X-Ray, Film Marking, Radiographic	Radiology	Class 1	892.1640	2024-10-16
FPO	Stretcher, Wheeled	General Hospital	Class 2	880.6910	2024-10-16
JRM	Freezer	Clinical Chemistry	Class 1	862.2050	2024-10-16
FLH	Washer Of Body Waste Receptacles	General Hospital	Class 1	880.6800	2024-10-16
FNG	Lift, Patient, Ac-Powered	General Hospital	Class 2	880.5500	2024-10-16
INQ	Table, Powered	Physical Medicine	Class 1	890.3760	2026-01-04
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2024-10-16
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2026-01-04
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2024-10-16

Official Correspondent

DORIS LIU

US Agent Details

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

Related Public Records

Same Entity

Jiangsu Rooe 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
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20
K912769	Century Manufacturing Co.	PATIENT LIFT AND TRANSPORT	1991-10-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0023-05	Stryker Medical	2	Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092.

Similar Registrations

Registration Number	Establishment Name	Location
3017911818	HANGZHOU STELLARMED MEDICAL TECHNOLOGY CO.,LTD	Hangzhou Zhejiang, CN
3030192580	XIAMEN LIYUAN METAL. CO.,LTD.	Xiamen Fujian, CN
3014383485	HUBEI YINKANG MEDICAL EQUIPMENT CO., LTD	Xiaogan Hubei, CN
3013404959	Viant San Antonio, Inc.	San Antonio, TX, US
3010373530	JIANGSU KELING MEDICAL APPLIANCES CO.,LTD.	Yangzhou Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014739961. Last updated year: 2026. Please use registration number 3014739961 when referencing this establishment in official correspondence.