Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010321647

FEI Number

3010321647

Entity Name

ZHEJIANG RUNQIANG MEDICAL INSTRUMENTS CO.,LTD.

City/State/Country

Jiaxing Zhejiang, CN

Establishment Address

599 Ruifeng Street, Gaozhao District, Xiuzhou District, Jiaxing Zhejiang 314031, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Zhejiang Runqiang Medical Instruments Co.,Ltd. (Owner Number: 10045244)

Owner / Operator Contact Address

599 Ruifeng Street, Gaozhao District, Xiuzhou District, Jiaxing, CN-ZJ 314031, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medline Reinforced Epidural Catheter Epidural Guider Suction Tube HairMax LaserComb Ultima 12; HairMax LaserComb Ultima 9; HairMax Pro 12 LaserComb; HairMax Professional 12 HairClub Ultima 12; HairClub Ultima 9 Classic; HairMax Advanced 7; HairMax LaserComb Prima 7; HairMax LaserComb Prima 9 Syringe-Syringe adapter, Needle Hub Cap, Epidural Catheter Feeder DASH 6® NRFit: Lock Syringe, Slip Syringe, Plastic LOR Device, Introducer Needle, Syringe Caps, Drawing Up Filter Straw Blunt Drawing Up Needle (with and without filter), Bacterial Disc Filter, Epidural Flat Filter, Tuohy Borst Adapter Medline Epidural Catheter HairMax Laser 202; HairMax Laser 272; HairMax Laser80 Needleless airtight infusion connector protector (Swab Cap)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2019-03-27
OGE	Epidural Anesthesia Kit	Anesthesiology	Class 2	868.5120	2016-07-27
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2014-11-25
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2022-04-28
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2021-04-12
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2021-04-12
BSN	Filter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5130	2021-04-12
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-04-12
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2016-03-28
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2023-02-08
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2019-03-27

Official Correspondent

Jianqiang Ma

US Agent Details

James H. Liao Email: james@sino2us.com Phone: (310) 3758169

Related Public Records

Same Entity

Zhejiang Runqiang Medical Instruments 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
K072702	Stryker Instruments, Instruments Div.	STRYKER ANTIMIC CATHETER	2008-03-19
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010321647. Last updated year: 2026. Please use registration number 3010321647 when referencing this establishment in official correspondence.