Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010373530

FEI Number

3010373530

Entity Name

JIANGSU KELING MEDICAL APPLIANCES CO.,LTD.

City/State/Country

Yangzhou Jiangsu, CN

Establishment Address

18#, Xiaoguanqiao Road, Jiangyang Industrial Park, Yangzhou Jiangsu 225008, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Jiangsu Keling Medical Appliances Co.,Ltd. (Owner Number: 10050477)

Owner / Operator Contact Address

18#, Xiaoguanqiao Road, Jiangyang Industrial Park, Yangzhou, CN-JS 225008, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Gynecological examination table, delivery bed walking aid stick rollator rollator walking aid suction machine anesthesia cabinet, table electrical hospital bed shower chair manual hospital bed x ray viewer examination light medical trolley, examination couch hospital stretcher hydrualic operation table foldable screen operation light

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	2015-11-24
IPR	Crutch	Physical Medicine	Class 1	890.3150	2021-10-25
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2015-11-24
BRY	Cabinet, Table And Tray, Anesthesia	Anesthesiology	Class 1	868.6100	2015-11-24
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2015-11-24
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2025-12-08
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2015-11-20
IXC	Illuminator, Radiographic-Film	Radiology	Class 1	892.1890	2015-11-24
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2025-12-08
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2015-11-20
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2015-11-20
FSE	Table, Operating-Room, Manual	General, Plastic Surgery	Class 1	878.4950	2015-11-20
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2025-12-08
EBA	Light, Surgical Headlight	Dental	Class 1	872.4630	2015-11-24

Official Correspondent

LU Liu

US Agent Details

hui hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

Jiangsu Keling Medical Appliances 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
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K851742	Burton Medical Products Corp.	MEDICAL EXAMINATION LIGHTS	1985-05-13

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
3014739961	JIANGSU ROOE MEDICAL TECHNOLOGY CO., LTD.	Zhangjiagang City Jiangsu, CN
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

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010373530. Last updated year: 2026. Please use registration number 3010373530 when referencing this establishment in official correspondence.