Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3037012186

FEI Number

3037012186

Entity Name

SHANGHAI NO. 2 MEDICAL COLLEGE DUHANG MEDICAL EQUIPMENT FACTORY

City/State/Country

Shanghai, CN

Establishment Address

No. 618, Jianyun Road, Zhoupu Town, Shanghai 201318, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Shanghai No. 2 Medical College Duhang Medical Equipment Fact (Owner Number: 10092805)

Owner / Operator Contact Address

No. 618, Jianyun Road, Zhoupu Town,, Shanghai, CN-NOTA 201318, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Aluminum mouldable splint, Body splint, Finger splint Manual Resuscitator Air Mattress Hospital Bed, Electric Hospital Bed CABINET, TABLE AND TRAY, ANESTHESIA, Cabinet Shelf Examination Table TABLE AND ATTACHMENTS, OPERATING-ROOM, Operating Table Accessories, Operating-room, Table (kit) Shower chair Screen Medical Chair CHAIR AND TABLE, MEDICAL; Attendant Chair; Treat-waiting Chair; Electric dialysis chair, Bedside Locker, Overbed Table, Whole reflector lamp, LED operation lamp, Reflector shadowless lamp, Operating Light BED, MANUAL; Nursing bed; Manual examination bed, Manual Hospital Bed Stretcher, Wheeled Bed Mattress, Mattress STRETCHER, HAND-CARRIED, Stretcher Dental Unit, ECG, Surgical Equipment; Monitoring Equipment: Monitor, Infant Incubator, Sphygmomanometer Treatment Equipment: Anesthesia Machine, Ventilator, Oxygen Generator, Infusion Pump, Suction Device, First aid kit Washing Sink Crutch Mortuary Refrigerator Trash Can; Mortuary Equipment: Corpse Storage Shelf, Autopsy Table, Body bag, Corpse Transportation Trolley, Wheel Chair Dialysis Chair Sputum suction unit, Manual suction unit, Electric suction unit Rollator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2025-02-20
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2025-02-20
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2025-02-20
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2025-02-20
BRY	Cabinet, Table And Tray, Anesthesia	Anesthesiology	Class 1	868.6100	2025-02-20
INQ	Table, Powered	Physical Medicine	Class 1	890.3760	2025-02-20
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2025-02-20
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2025-02-20
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2025-02-20
HOK	Screen, Tangent, Projection, Ac-Powered	Ophthalmic	Class 1	886.1810	2025-02-20
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2025-02-20
FQP	Lamp, Operating-Room	General, Plastic Surgery	Class 2	878.4580	2025-02-20
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2025-02-20
FPO	Stretcher, Wheeled	General Hospital	Class 2	880.6910	2025-02-20
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2025-02-20
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2025-02-20
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2025-02-20
OVR	Kit, First Aid, Talking	General, Plastic Surgery	Class 1	878.4014	2025-02-20
FLH	Washer Of Body Waste Receptacles	General Hospital	Class 1	880.6800	2025-02-20
IPR	Crutch	Physical Medicine	Class 1	890.3150	2025-02-20
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2025-02-20
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2025-02-20
FIA	Chair, Dialysis, Unpowered, Without Scales	Gastroenterology, Urology	Class 1	876.5820	2025-02-20
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2025-02-20
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2025-02-20

Official Correspondent

Tracy Shi

US Agent Details

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

Related Public Records

Same Entity

Shanghai No. 2 Medical College Duhang Medical Equipment Fact

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
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K933337	R & D Batteries, Inc.	R AND D BATTERY REPLACEMENT	1994-04-05
K873766	Bowen & Company, Inc.	STERNAL POWER AWL	1988-11-14

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.

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3018759542	DIMENSION ORTHO Inc.	Philadelphia, PA, US
3009605026	JIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.	Yancheng Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3037012186. Last updated year: 2026. Please use registration number 3037012186 when referencing this establishment in official correspondence.