Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017268832

FEI Number

3017268832

Entity Name

HUIZHOU KAIYI TECHNOLOGY CO.,LTD

City/State/Country

Huizhou Guangdong, CN

Establishment Address

7# Xingqian Road 2, Fuxing Industrial Zone, Yuanzhou Town Huizhou ,Guangdong,China, Huizhou Guangdong 516123, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Huizhou Kaiyi Technology Co.,ltd (Owner Number: 10072905)

Owner / Operator Contact Address

7# Xingqian Road 2, Fuxing Industrial Zone, Yuanzhou Town Huizhou ,Guangdong,China, Huizhou, CN-GD 516123, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medicine Chamber Spacers oxygen masks

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCL	Blower, Powder, Ent	Ear, Nose, Throat	Class 1	874.5220	2023-10-17
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2024-11-24

Official Correspondent

Tianxiang Zeng

US Agent Details

WINNIE Zhu Business: Umedwings Solution USA Email: Agent@Umedwings.Us Phone: (224) 4023150

Related Public Records

Same Entity

Huizhou Kaiyi Technology Co.,ltd

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017268832. Last updated year: 2026. Please use registration number 3017268832 when referencing this establishment in official correspondence.