Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009312584

FEI Number

3009312584

Entity Name

Rayco Electronic Ltd.

City/State/Country

Dong Guan City Guangdong, CN

Establishment Address

Ya Yuan Industial Area , Nan Cheng District,, Dong Guan City Guangdong 523083, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Rayco Electronic Ltd. (Owner Number: 10037853)

Owner / Operator Contact Address

Flat 2, 23/F,, 16-26 Wang Wo Tsai St.,, Tsuen Wan, HK-NOTA 00000, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FC-1200 HC-310 EA-100 FC-900 FC-1000 FC-810 FC-800 FC-1500 HC-313 MedAIRE 2 MedAIRE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DJZ	Devices, Breath Trapping, Alcohol	Clinical Toxicology	Class 1	862.3050	2011-08-24
DJZ	Devices, Breath Trapping, Alcohol	Clinical Toxicology	Class 1	862.3050	2019-08-02
NRH	System, Breath Measurement	Clinical Chemistry	Class 1	862.1820	2021-10-18

Official Correspondent

Ambrose Lee

US Agent Details

FDAIMPORTS.COM LLC Email: registration@fdaimports.com Phone: (410) 2202800

Related Public Records

Same Entity

Rayco Electronic Ltd.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009312584. Last updated year: 2026. Please use registration number 3009312584 when referencing this establishment in official correspondence.