Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007031002

FEI Number

3007031002

Entity Name

KANGHUI MEDICAL TECHNOLOGY (SUZHOU) CO.,LTD

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

Industrial Park of Guizhuang, Taicang, Jiangsu, Suzhou Jiangsu 215425, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KANGHUI MEDICAL TECHNOLOGY (SUZHOU) CO.,LTD (Owner Number: 10025645)

Owner / Operator Contact Address

Industrial Park of Guizhuang, Taicang, Jiangsu, Suzhou, CN-JS 215425, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

JIU JIU YAN YANG DH-XD101, DH-XD102, DH-XD104, DH-XD107, DH-XS104, DH-XS105 DH-C101B01), OBSTETRICAL TABLE SERIES (DH-C102, DH-C102A, DH-C102B, DH-C102C) LDR BED SERIES (DH-C101A01, DH-C101A02, DH-C101A03, DH-C101A04, DH-C101A05, DH-C101A06, DH-C101A07, DH-C101A08, DH-S104E, DH-S106 DH-S101, DH-S102A, DH-S102C, DH-S102D, DH-S104B, DH-S105A, DH-S105B, DH-S106A, DH-S106B, DH-S104A, DH-S104C, DH-S104D, JY-LT, JY-LT(J), JY-LT(L), JY-ZT JY-YWD01, JY-YWD02, JY-YWD03, JY-YWD04, JY-YWD06, JY-YWY01, JY-YWY02, JY-ZXQ(D), JY-BX-02, JY-BX-03, JY-YWT01, JY-YWT02, JY-YY Powered Table JY-ZL01 Electric Nursing Bed Series (DH-N01, DH-N101A, DH-N101B, DH-N101C, DH-N102, DH-N102A, DH-N102B, DH-N103, DH-N104, DH-N105, DH-B01, DH-B02, DH-B03, DH-B04, DH-B05) DH-S103A, DH-S103A-01, DH-S103B, DH-S103B-01, DH-ZS01, DH-ZS01A, DH-ZS01B

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LGX	Table, Examination, Medical, Powered	General, Plastic Surgery	Class 1	878.4960	2013-01-04
FNG	Lift, Patient, Ac-Powered	General Hospital	Class 2	880.5500	2017-09-21
FML	Chair, Blood Donor	General Hospital	Class 1	880.6140	2013-01-04
HDD	Table, Obstetrical, Ac-Powered (And Accessories)	Obstetrics/Gynecology	Class 2	884.4900	2020-01-03
KNC	Table, Obstetric (And Accessories)	Obstetrics/Gynecology	Class 2	884.4900	2024-05-10
PCD	Powered Stairway Chair Lift	Physical Medicine	Class 2	890.5150	2013-01-04
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2013-01-04
INQ	Table, Powered	Physical Medicine	Class 1	890.3760	2024-05-10
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2013-01-04
JEA	Table, Surgical With Orthopedic Accessories, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2015-12-24

Official Correspondent

Lizhong Chen

US Agent Details

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

Related Public Records

Same Entity

KANGHUI MEDICAL TECHNOLOGY (SUZHOU) 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
K912769	Century Manufacturing Co.	PATIENT LIFT AND TRANSPORT	1991-10-02
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018	Handicare AB Maskinvagen	1	Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
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

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3015978022	INSPITAL MEDICAL TECHNOLOGY GMBH	Neuss North Rhine-Westphalia, DE
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007031002. Last updated year: 2026. Please use registration number 3007031002 when referencing this establishment in official correspondence.