Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016674858

FEI Number

3016674858

Entity Name

HANGZHOU RUIHAO MEDICAL TECHNOLOGY LTD

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

1812,BLOCK B,YUHUA BUILDING, NO.196 ZHENHUA ROAD, XIHU DISTRICT, HANGZHOU CHINA, Hangzhou Zhejiang 310012, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

HangZhou Ruihao Medical Technology Ltd. (Owner Number: 10062740)

Owner / Operator Contact Address

1812,BLOCK B,YUHUA BUILDING, NO.196 ZHENHUA ROAD, XIHU DISTRICT, HANGZHOU CHINA, Hangzhou, CN-ZJ 310012, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Suction Canister and Tubing Set Isolation Gown-Level 3 Tonsil Snare Tocar Disinfecting Cap Disposable synthetic Nitrile Gloves Suture Passer - Tube, Suture Retriever - Tube Dressing, Wound, Occlusive Wound Drainage Reservoir

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2020-11-13
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-11-13
KBZ	Snare, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2020-03-05
KCI	Trocar, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2020-03-05
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2020-11-13
QLB	N/A	N/A	Class N/A	N/A	2021-01-06
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2022-12-09
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2022-01-05
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2020-06-17

Official Correspondent

Lu Zhang

US Agent Details

Siddiq Azeem Business: A&S International Email: siddiq@asint.biz Phone: (815) 2541110

Related Public Records

Same Entity

HangZhou Ruihao Medical Technology 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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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3043165985	CHAFON TECHNOLOGY CO., LIMITED	TSIM SHA TSUI Hong Kong, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016674858. Last updated year: 2026. Please use registration number 3016674858 when referencing this establishment in official correspondence.