Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010580321

FEI Number

3010580321

Entity Name

HAIYAN KANGYUAN MEDICAL INSTRUMENT CO.,LTD.

City/State/Country

JiaXing Zhejiang, CN

Establishment Address

Songpo East Rd.,Shendang Town, Haiyan, JiaXing City, Zhejiang Province, JiaXing Zhejiang 314311, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Haiyan Kangyuan Medical Instrument Co.,Ltd. (Owner Number: 10045242)

Owner / Operator Contact Address

Songpo East Rd.,Shendang Town, Haiyan, JiaXing City, Zhejiang Province, JiaXing, CN-ZJ 314311, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

KangYuan MADEWELL Eye Shield MADEWELL Face shield KangYuan KANGYUAN Laryngeal Mask Airway Reinforce 1#,1.5#,2#,2.5#,3#,4#,5#,6# KANGYUAN Laryngeal Mask Airway for Single Use 1#,1.5#,2#,2.5#,3#,4#,5#,6# KANGYUAN Laryngeal Mask Airway Reused 1#,1.5#,2#,2.5#,3#,4#,5#,6# Medline Female External Catheter KANGYUAN Catheter Suction, and Catheter Suction Kit, FR6,FR8,FR10,FR12,FR14,FR16,FR18,FR20,FR24 KangYuan KangYuan KangYuan MADEWELL KANGYUAN OROPHARYNGEAL AIRWAY 3#,3.5#,4#,4.5#,5#,5.5#,6#,7#,8#,9#,10#,11#,12# MEDLINE CATHETER KangYuan EN-PLUG

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2018-08-24
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-04-10
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-31
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2018-04-18
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2013-10-30
NZU	Collector, Urine, Powered, Non Indwelling Catheter	Gastroenterology, Urology	Class 1	876.5250	2021-12-06
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2013-10-30
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2018-04-18
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2018-04-16
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2018-04-18
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2024-01-22
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2013-10-30
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2019-06-24
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2018-04-18
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2024-06-16

Official Correspondent

Tracy Qiu

US Agent Details

Charles Shen Business: Manton Business and Technology Services Email: cyshen@aol.com Phone: (608) 2179358

Related Public Records

Same Entity

Haiyan Kangyuan 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
K233013	Silq Technologies Corporation	2-Way 100% Silicone Cleartract Catheter	2024-01-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
Z-0036-04	VIASYS Med Systems	1	Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120
Z-0037-04	VIASYS Med Systems	1	Sideport Kit, consisting of an adjustable sideport valve and an O2 port elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83166

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010580321. Last updated year: 2026. Please use registration number 3010580321 when referencing this establishment in official correspondence.