Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017911818

FEI Number

3017911818

Entity Name

HANGZHOU STELLARMED MEDICAL TECHNOLOGY CO.,LTD

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

Room 212, Floor 2, Building 2, No.9 Taiji Road, Yunhe Street, Yuhang District, Hangzhou Zhejiang 311000, CN

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Hangzhou Stellarmed Medical technology Co.,Ltd (Owner Number: 10079659)

Owner / Operator Contact Address

Room 212, Floor 2, Building 2, No.9 Taiji Road, Yunhe Street, Yuhang District, Hangzhou, CN-ZJ 311000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Device Organizer Poly trap Tray,Surgical, Instrument-Water Basin,Tray Coloshield Procedure Drape, Non-Sterile, Single Use Bedding, Disposable, Medical-Transport Pad Non-Surgical isolation gown ESD Specimen Tray,with pins Cleaner,Ultrasonic,Medical Instrument-Endoscopy Kit Bite Block Single use biopsy forceps Lubricant, Patient-Sterile Lubricating Jelly

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2020-12-17
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2025-06-30
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-02-21
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2020-12-17
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2021-09-18
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2022-09-27
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2020-12-17
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2022-02-21
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2021-09-18
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2020-12-17
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2021-09-18

Official Correspondent

Kerry Hu

US Agent Details

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

Related Public Records

Same Entity

Hangzhou Stellarmed 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
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20
K820587	Abco Dealers, Inc.	WET PACK LINE OF PRODUCTS	1982-03-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

Similar Registrations

Registration Number	Establishment Name	Location
3014739961	JIANGSU ROOE MEDICAL TECHNOLOGY CO., LTD.	Zhangjiagang City Jiangsu, CN
3030192580	XIAMEN LIYUAN METAL. CO.,LTD.	Xiamen Fujian, CN
3014383485	HUBEI YINKANG MEDICAL EQUIPMENT CO., LTD	Xiaogan Hubei, CN
3013404959	Viant San Antonio, Inc.	San Antonio, TX, US
3010373530	JIANGSU KELING MEDICAL APPLIANCES CO.,LTD.	Yangzhou Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017911818. Last updated year: 2026. Please use registration number 3017911818 when referencing this establishment in official correspondence.