Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030839824

FEI Number

3030839824

Entity Name

HANGZHOU ENDO MEDICAL INSTRUMENT CO.,LTD

City/State/Country

hangzhou Zhejiang, CN

Establishment Address

ROOM 102, 6 BUILDING, NO.1688 CHUNJIANG EAST ROAD, TONGLU, hangzhou Zhejiang 311500, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HANGZHOU ENDO MEDICAL INSTRUMENT CO.,LTD (Owner Number: 10090557)

Owner / Operator Contact Address

ROOM 102, 6 BUILDING, NO.1688 CHUNJIANG EAST ROAD, TONGLU, hangzhou, CN-ZJ 311500, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NEEDLE, ASPIRATION AND INJECTION, REUSABLE FCL - FORCEPS, BIOPSY, NON-ELECTRIC HFB - FORCEPS, BIOPSY, GYNECOLOGICAL FHQ - HOLDER, NEEDLE, GASTROENTEROLOGIC HTZ - INSTRUMENT, CUTTING, ORTHOPEDIC GDI - DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY LRW - SCISSORS, GENERAL, SURGICAL KTE - TROCAR, ENT GCJ - Laparoscope, general & plastic surgery FBM - Cannula and trocar, suprapubic, non-disposable LRC - INSTRUMENT, ENT MANUAL SURGICAL INSTRUMENT, LIGATURE PASSING AND KNOT TYING NWV - Laparoscopic accessories, gynecologic ERA - OTOSCOPE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	2024-04-15
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2024-04-17
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2024-04-16
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2024-04-22
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2024-04-17
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-04-15
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-04-16
KTE	Trocar, Ent	Ear, Nose, Throat	Class 1	874.4420	2024-04-17
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-03-13
FBM	Cannula And Trocar, Suprapubic, Non-Disposable	Gastroenterology, Urology	Class 1	876.5090	2024-04-16
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2024-04-17
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2024-04-17
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2024-04-17
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2025-01-03

Official Correspondent

Ana Xiao

US Agent Details

Laura Strelitzki Email: lstrelitzki@gmail.com Phone: (321) 9483563

Related Public Records

Same Entity

HANGZHOU ENDO MEDICAL INSTRUMENT 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
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030839824. Last updated year: 2026. Please use registration number 3030839824 when referencing this establishment in official correspondence.