JIANGSU HANHENG MEDICAL TECHNOLOGY CO., LTD

FDA Device Registration & Listing · Changzhou Jiangsu, CN · Registration 3016159368

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016159368
FEI Number
3016159368
Entity Name
JIANGSU HANHENG MEDICAL TECHNOLOGY CO., LTD
City/State/Country
Changzhou Jiangsu, CN
Establishment Address
#118 Xinyuan 3rd Road, Xinbei District, Changzhou Jiangsu 213031, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Jiangsu HanHeng Medical Technology Co., Ltd (Owner Number: 10061791)
Owner / Operator Contact Address
#118 Xinyuan 3rd Road, Xinbei District, Changzhou, CN-JS 213031, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

A-0116, A-0117, A-0118, A-0119, A-0120, A-0121, A-02, A-03, A-04, A-04-50, A-04-65, A-04-70, A-04-75, A-04-80, A-04-85, Disposable Sampling Swab (non-sterile): A-01, A-01-30, A-01-50, A-01-65, A-01-70, A-01-75, A-01-80, A-01-91, A-010, G-012, G-013, G-014, G-014-30, G-014-40, G-014-50, G-014-60, G-014-70, G-014-80, G-015, G-015-7621C, G-015-2193C, G-016, G-0131, G-0132, G-0133, G-0134, G-0135, G-0136, G-0137, G-0138, G-02, G-020, G-016-60, G-016-70, G-016-80, G-017, G-018, G-08, G-080, G-081, G-082, G-09, G-090, G-091, G-092, G-11, ZCY-03, ZCY-04 G-032, G-04, G-040, G-041, G-042, G-05, G-050, G-051, G-052, G-06, G-060, G-061, G-062, G-063, G-064, G-065, G-066, A-04-91, A-04-95, A-04-100, A-040-12, A-041, A-042, A-05, A-06, A-07, A-08, A-09, A-10, A-11, A-12, A-13, B, C, C-01, G-067, G-068, G-069, G-0610, G-0611, G-0612, G-0613, G-0614, G-0615, G-0616, G-0617, G-0618, G-07, G-070, G-071, G-072, G-019, G-0110, G-0111, G-0112, G-0113, G-0114, G-0115, G-0116, G-0117, G-0118, G-0119, G-021, G-022, G-03, G-030, G-031, A-010-75, A-011, A-012, A-013, A-014, A-015, A-016, A-017, A-018, A-019, A-0110, A-0111, A-0112, A-0113, A-0114, A-0115, C-010, C-02, C-03, C-030, C-031, C-032, C-04, C-040, C-041, C-042, C-05, C-050, C-051, C-052, D, D-01, D-02, D-03, G-016-30, G-016-40, G-016-50, G-0120, G-0121, G-0122, G-0123, G-0124, G-0125, G-0126, G-0127, G-0128, G-0129, G-0130, E, E-01, E-02, E-03, E-000, E-010, E-020, E-030, F, F-01, F-02, F-03, F-000, F-010, F-020, F-030, G-01, G-010, G-011, Disposable Sampling spoon Disposable urine drainage bags Disposable Virus Sampling Swab Kit Disposable suction catheter,Disposable suction connecting tubes with Yankauer Disposable medical pad Steradian Sheild Disposable rectal tube Disposable mucus extrators Disposable Amniotic hook Disposable Endometrial Sampling Kit Disposable I.D. bracelet Disposable nasal oxygen cannula Disposable medical gloves Disposable vaginal expander Disposable nelaton catheter Disposable Umbilical Cord Clamp Medical hand wash brush

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital Class 1 880.6025 2026-04-27
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2019-11-20
KNX Collector, Urine, (And Accessories) For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2019-11-20
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2020-03-23
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2019-11-20
ERY Drape, Surgical, Ent General, Plastic Surgery Class 2 878.4370 2019-11-20
KPY Shield, Protective, Personnel Radiology Class 1 892.6500 2025-08-28
OOW Applicator For Rectal Suppository Gastroenterology, Urology Class 1 876.4730 2019-11-20
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 2019-11-20
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2019-11-20
OKU Emergency Obstetrical Kit Obstetrics/Gynecology Class 1 884.4520 2019-11-20
FZZ Marker, Skin General, Plastic Surgery Class 1 878.4660 2019-11-20
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2019-11-20
IWP Radiographic Protective Glove Radiology Class 1 892.6500 2019-11-20
HIB Speculum, Vaginal, Nonmetal Obstetrics/Gynecology Class 2 884.4530 2019-11-20
EYK Connector, Ureteral Catheter Gastroenterology, Urology Class 1 876.5130 2019-11-20
FOD Device, Occlusion, Umbilical General Hospital Class 1 880.5950 2019-11-20
GEC Brush, Scrub, Operating-Room General, Plastic Surgery Class 1 878.4800 2019-11-20

Official Correspondent

Yueming Xia

US Agent Details

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

Related Public Records

Same Entity

Jiangsu HanHeng 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
K791969 Medline Industries, Inc. DYNACOR STERILE CLOSED SYS. DRAINAGE BAG 1979-11-05
K883982 Iberhospitex, S.A. DRENOVAC 1989-02-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2013 Invuity, Inc. 2
BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016159368. Last updated year: 2026. Please use registration number 3016159368 when referencing this establishment in official correspondence.
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