Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015139770

FEI Number

3015139770

Entity Name

XI'AN HAIYE MEDICAL EQUIPMENT CO,.LTD.

City/State/Country

Xi'an City Shaanxi, CN

Establishment Address

Factory Building 9, No. 8, Lijun Road, Fengjing Industrial Park, Huyi District, Xi'an City, Xi'an City Shaanxi 710300, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Xi'an Haiye Medical Equipment co,.Ltd. (Owner Number: 10058939)

Owner / Operator Contact Address

Factory Building 9, Shaanxi Guanghui Science and Technology Industrial Park, No. 8, Lijun Road, Xi'an City, CN-SN 710300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Video Laryngoscope Blade Disposable Fiber Optic Laryngoscope Blade Disposable Fiber Optic Laryngoscope HYHJ-KP3, HYHJ-KP5, HYHJ-KP3F, HYHJ-KP5F, HYHJ-KP3C, HYHJ-KP5C, HYHJ-KM3, HYHJ-KM5 HYHJ-KM3F, HYHJ-KM5F, HYHJ-KM3C, HYHJ-KM5C Video Laryngoscopes-HYHJ-1320, HYHJ-KC, HYHJ-1330, HYHJ-1330I, HYHJ-1330 II, HYHJ-1330 III

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2018-11-12
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2018-11-12

Official Correspondent

No official correspondent registered.

US Agent Details

James Wang Business: LLINS TECHNOLOGY INC Email: fda-rep@llins-tech.com Phone: (720) 2171916

Related Public Records

Same Entity

Xi'an Haiye 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-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-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.

Similar Registrations

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3004530184	ANDERSEN CALEDONIA LTD	Bellshill Scotland, GB
1824226	KING SYSTEMS CORPORATION.	Noblesville, IN, US
9681384	Covidien	Ciudad Juarez Chihuahua, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015139770. Last updated year: 2026. Please use registration number 3015139770 when referencing this establishment in official correspondence.