Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013460719

FEI Number

3013460719

Entity Name

ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

Room 101-1, 201-1, 301, 401, Building 50, No.650 Hongfeng Road, Donghu Street, Linping District, Hangzhou Zhejiang 311100, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Zhejiang Chuangxiang Medical Technology Co., LTD. (Owner Number: 10053736)

Owner / Operator Contact Address

Room 101-1, 201-1, 301, 401, Building 50, No.650 Hongfeng Road, Donghu Street, Linping District, Hangzhou, CN-ZJ 311100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sclerotherapy Needle Polyp Trap Single Use Grasping Forceps Single Use Urethral Dilator Single Use Guidewire/Single Use Urinary Guidewire Air/Water Bottle Tubing, CO2 Source Tubing Chuangxiang Single Use Ureteral Access Sheath Cleaning Brush Single Use Biopsy Forceps Single Use Hemoclip Disposable Valve Sets; MD-A-AW01; MD-B-AW01; Sterilization, endoscopic Compatibility:Olympus 140/160/180/190/240/260 Single Use Cytology Brush Single Use Retrieval Snare Net, Cold Snare Disposable Biopsy Valve Single use stone retrieval balloons Single Use Biopsy Forceps Single Use Grasping Forceps Rotatable Snares, Non-Rotatable Snares Chuangxiang In-Sight Multi-Band Ligator Disposable Bite Block Single Use Grasping Forceps Colonoscopy holding device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2022-03-01
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2017-02-22
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2019-03-06
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2023-05-17
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2019-03-06
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2023-09-22
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2023-09-22
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2020-08-23
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2022-06-01
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2017-01-05
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2017-02-08
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2018-04-02
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2019-12-30
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2019-12-30
FDX	Endoscopic Cytology Brush	Gastroenterology, Urology	Class 2	876.1500	2022-08-01
FGX	Snare, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2017-04-25
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2018-05-15
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2026-03-09
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	Class 1	884.1690	2019-03-06
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2018-04-02
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2020-01-06
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2020-01-06
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2017-02-08
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2020-04-03
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2021-07-15

Official Correspondent

Lucius Long

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: Regrek.Cs@Hotmail.Com Phone: (302) 6089028

Related Public Records

Same Entity

Zhejiang Chuangxiang 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
K820587	Abco Dealers, Inc.	WET PACK LINE OF PRODUCTS	1982-03-26
K230752	FUJIFILM Healthcare Americas Corporation	Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)	2023-09-15
K902734	Olympus Corp.	PR CANNULAS	1990-08-22
K200745	United States Endoscopy Group, Inc.	Lariat, Hot/Cold Snare	2020-04-21
K000397	Boston Scientific Corp	SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL	2000-03-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Z-0021-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4704
Z-0022-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4712
Z-0023-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4718
Z-0024-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4720

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3013526170	Jiangsu Vedkang Medical Science and Technology Co.,Ltd.	Changzhou Jiangsu, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013460719. Last updated year: 2026. Please use registration number 3013460719 when referencing this establishment in official correspondence.