Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016670149

FEI Number

3016670149

Entity Name

GUANGDONG GENIAL TECHNOLOGY CO., LTD.

City/State/Country

Zhaoqing Guangdong, CN

Establishment Address

I-6-05-02,11th Road, Area B, Guanfozhao Economic Cooperation Zone, Zhagang Town, Huaiji County, Zhaoqing Guangdong 526437, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guangdong Genial Technology CO., Ltd. (Owner Number: 10072762)

Owner / Operator Contact Address

I-6-05-02,11th Road, Area B, Guanfozhao Economic Cooperation Zone, Zhagang Town, Huaiji County, Zhaoqing, CN-GD 526437, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210014

PMA Number

N/A

All Registered Proprietary Names

Thermometer Models: T11,T11L,T12,T12C,T12D,T12E,T12L,T14,T14H,T15,T15B,T15ST15SC,T15SL,T16,T17,T17L,T18,T18B,T18C,T19,T19B,T19C,T19D T23, T24, T25, T26, T28, T28L, T28P Wearable Digital Thermometer, Model: T31 Finger Clip Pulse Oximeter, Model:GX3, GX5, GX7, GX9, GX11, GX13.GX4, GX6, GX8, GX10, GX12, GX14 Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85, T86, T87)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQZ	Thermometer, Clinical Color Change	General Hospital	Class 1	880.2900	2020-05-01
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2025-06-25
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-11-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-12-02
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2021-07-16

Official Correspondent

Yu Jun

US Agent Details

Terry Chai Email: terry.chai.nj@hotmail.com Phone: (908) 6361278

Related Public Records

Same Entity

Guangdong Genial Technology CO., Ltd.

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
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

Similar Registrations

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3012709011	THE GILBERT GROUP LLC	Chicago, IL, US
3010487482	TECFEN MEDICAL	Santa Barbara, CA, US
1250045	Tender Corporation	Littleton, NH, US
9680225	ONBO ELECTRONIC (SHENZHEN) CO. LTD.	SHENZHEN Guangdong, CN
3031700059	P BHOGILAL PVT LTD	Kolkata West Bengal, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016670149. Last updated year: 2026. Please use registration number 3016670149 when referencing this establishment in official correspondence.