Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009747810

FEI Number

3009747810

Entity Name

NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD

City/State/Country

Cixi Zhejiang, CN

Establishment Address

NO.208 Binjiang Road, Cixi High-tech Industrial Development Zone, Cixi Zhejiang 315301, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ningbo Huakun Medical Equipment Co.,ltd (Owner Number: 10041496)

Owner / Operator Contact Address

NO.208, Binjiang Road, Cixi High-tech Industrial Development Zone, Cixi, CN-ZJ 315301, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TUBING, PRESSURE AND ACCESSORIES-CPAP Tubing Catheter trimmer Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY DEVICE, FIXATION, TRACHEAL TUBE CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE) Disposable Hemostatic Clips CATHETERS, SUCTION, TRACHEOBRONCHIAL MASK, OXYGEN, NON-REBREATHING SUPPORT, BREATHING TUBE LARYNGOSCOPE, NON-RIGID laryngoscope, rigid--video laryngoscope Ultrasonic Scalpel Anesthesia Breathing Circuit Kit (Adult & Pediatric) BAG, RESERVOIR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2023-11-03
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-11-14
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-04-16
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2021-11-29
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2012-07-31
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2014-03-26
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2024-09-04
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2012-07-31
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2012-07-31
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2012-07-31
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2013-09-12
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2025-02-09
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	Class 1	868.5240	2019-02-21
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2012-07-31

Official Correspondent

Lei Xi

US Agent Details

Wen Xu Email: infor@believe-med.com Phone: (443) 8968583

Related Public Records

Same Entity

Ningbo Huakun Medical Equipment Co.,ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Z-0332-2022	Covidien Llc	U	Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009747810. Last updated year: 2026. Please use registration number 3009747810 when referencing this establishment in official correspondence.