Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021023752

FEI Number

3021023752

Entity Name

JIANA STERILIZATION TECHNOLOGY (HANGZHOU) CO., LTD

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

Building 1, Building 2, No. 58, Huaning Road, Yunhe Street, Linping District, Hangzhou Zhejiang 311103, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Jiana Sterilization Technology (Hangzhou) Co., LTD (Owner Number: 10083013)

Owner / Operator Contact Address

Building 1, Building 2, No. 58, Huaning Road, Yunhe Street, Linping District, Hangzhou City, Zhejiang Province, Hangzhou, CN-ZJ 311103, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cleaning Brush Single Use Retrieval Snare Net, Polypectomy Snare (NON-ELECTRICAL) Insulin pen needle Sclerotherapy Needle Air/Water Bottle Tubing, CO2 Source Tubing Rotatable Snares, Non-Rotatable Snares Polyp Trap Single Use Biopsy Forceps Single Use Urethral Dilator Single Use Hemoclip Single Use Grasping Forceps Single Use Ureteral Access Sheath Single Use Hemoclip Disposable Biopsy Valve Endoscopy Irrigation Tubing Single Use Cytology Brush Automatic Core Biopsy Instrument Probe Spacer Disposable Needle Guider

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2024-12-31
FGX	Snare, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2024-12-31
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-10-20
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-12-31
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2024-12-31
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2024-12-31
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2021-11-08
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2024-12-31
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2024-12-31
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2024-12-31
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2024-12-31
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2021-11-08
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-12-31
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2021-11-08
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2021-11-08
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2024-12-31
FDX	Endoscopic Cytology Brush	Gastroenterology, Urology	Class 2	876.1500	2024-12-31
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2024-01-17
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-01-17

Official Correspondent

Jun Zhou

US Agent Details

Wei ZHANG Business: 3dstocking Inc Email: ge@3dstocking.com Phone: (772) 9996108

Related Public Records

Same Entity

Jiana Sterilization Technology (Hangzhou) 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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K200745	United States Endoscopy Group, Inc.	Lariat, Hot/Cold Snare	2020-04-21
K923489	Cox Medical Ent., Inc.	COX DISPOSABLE RETRIEVAL DEVICES	1992-09-23
K230752	FUJIFILM Healthcare Americas Corporation	Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)	2023-09-15
K172344	Medax Srl Unipersonale	Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)	2017-11-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
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

Similar Registrations

Registration Number	Establishment Name	Location
3008819648	F.R.GALANTAI MANUFACTURING COMPANY LIMITED	Auckland, NZ
3031595576	SUZHOU SMH CO., LTD.	Suzhou Jiangsu, CN
3016965567	SAETTELE GMBH & CO. KG	Todtnau Baden-Wurttemberg, DE
3004091741	AXEL GENTNER GMBH	Tuttlingen Baden-Wurttemberg, DE
3011178147	GI SCIENTIFIC LLC	Mc Lean, VA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021023752. Last updated year: 2026. Please use registration number 3021023752 when referencing this establishment in official correspondence.