Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016010357

FEI Number

3016010357

Entity Name

KANGYIN ELECTRONIC TECHOLOGY COMPANY LIMITED

City/State/Country

Phu Ly Ha Nam, VN

Establishment Address

Lot D, D1 St., Chau Son Industrial Zone, Chau Son Ward, Phu Ly Ha Nam 30000, VN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

ONION CULTURE INDUSTRIAL CO., LIMITED (Owner Number: 10093868)

Owner / Operator Contact Address

Lot D, D1 St., Chau Son Industrial Zone, Chau Son Ward, Phu Ly, VN-63 30000, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ORAL IRRIGATOR, ONKY-6000 NASAL RINSE PACKETS, ONJEM-001 NASAL IRRIGATOR, CXN1-7000, ONKY-7000

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2025-07-25
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2025-07-25

Official Correspondent

ANTHONY FONG

US Agent Details

James St. Wu Business: Humiss Inc. Email: fda-reg@humiss.com Phone: (720) 7595888

Related Public Records

Same Entity

ONION CULTURE INDUSTRIAL CO., LIMITED

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
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016010357. Last updated year: 2026. Please use registration number 3016010357 when referencing this establishment in official correspondence.