Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010373263

FEI Number

3010373263

Entity Name

JIANGSU SAIKANG MEDICAL EQUIPMENT CO., LTD

City/State/Country

Zhangjiagang Jiangsu, CN

Establishment Address

NO.35 Lehong Road, Modern Agriculture Demonstration Park, Zhangjiagang Jiangsu 215600, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Jiangsu Saikang Medical Equipment Co., Ltd (Owner Number: 10043618)

Owner / Operator Contact Address

NO.35 Lehong Road, Modern Agriculture Demonstration Park, Zhangjiagang, CN-JS 215600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Washing sink Manual Resuscitator screen First aid kit Sputum suction unit Manual suction unit Electric suction unit IV stand examination table Body splint Aluminum mouldable splint Finger splint Rollator Electric parturition bed, Electric surgical table, Electric delivery bed, Electric gynecological table, Tilting table Mortuary Refrigerator Trash Can; Mortuary Equipment: Corpse Storage Shelf, Autopsy Table, Body bag, Corpse Transportation Trolley, Whole reflector lamp LED operation lamp Reflector shadowless lamp Curtain, Track, Stainless Steel Screen Sterilizer Bed Mattress Dental unit Stapler BED, MANUAL; Nursing bed; Manual examination bed; Examination couch Stretcher, wheeled

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLH	Washer Of Body Waste Receptacles	General Hospital	Class 1	880.6800	2017-11-13
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2017-11-13
HOK	Screen, Tangent, Projection, Ac-Powered	Ophthalmic	Class 1	886.1810	2020-11-15
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2013-03-06
OVR	Kit, First Aid, Talking	General, Plastic Surgery	Class 1	878.4014	2017-11-13
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2017-11-13
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2020-11-15
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2013-03-06
INQ	Table, Powered	Physical Medicine	Class 1	890.3760	2020-11-15
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2017-11-13
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2017-11-13
GDC	Table, Operating-Room, Electrical	General, Plastic Surgery	Class 1	878.4960	2017-11-13
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2023-12-03
FQP	Lamp, Operating-Room	General, Plastic Surgery	Class 2	878.4580	2017-11-13
IWQ	Curtain, Protective, Radiographic	Radiology	Class 1	892.6500	2023-11-16
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2025-03-20
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2017-11-13
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2025-03-20
BRY	Cabinet, Table And Tray, Anesthesia	Anesthesiology	Class 1	868.6100	2013-03-06
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2017-11-13
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2013-03-06
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2013-03-06
FPO	Stretcher, Wheeled	General Hospital	Class 2	880.6910	2020-04-09

Official Correspondent

Zhixiang Cai

US Agent Details

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

Related Public Records

Same Entity

Jiangsu Saikang Medical Equipment 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
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21
K221629	Covidien	Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters)	2023-02-22
K231491	Covidien	TA Stapler and Loading Unit with DST Series Technology	2023-08-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0037-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0038-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0016-2007	Sunrise Medical CCG, Inc.	2	Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
Z-0017-2007	Hill-Rom, Inc.	2	Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200.
Z-0019-2015	Arjo Hospital Equipment AB Verkstadsvagen	2	ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.

Similar Registrations

Registration Number	Establishment Name	Location
3006542588	MEIKO MASCHINENBAU GMBH & CO. KG	OFFENBURG Baden-Wurttemberg, DE
3015495690	GUANGZHOU NUONING MEDICAL SUPPLIES CO.,LTD	Guangzhou Guangdong, CN
8043410	VERNACARE CANADA, INC.	Maple Ontario, CA
3007420694	ArjoHuntleigh Polska Sp. zo.o.	Poznan Wielkopolskie, PL
3014739961	JIANGSU ROOE MEDICAL TECHNOLOGY CO., LTD.	Zhangjiagang City Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010373263. Last updated year: 2026. Please use registration number 3010373263 when referencing this establishment in official correspondence.