Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016195105

FEI Number

3016195105

Entity Name

Dongguan Sheng Yan Industrial Co., Ltd.

City/State/Country

DongGuan Guangdong, CN

Establishment Address

702, 7th Floor, Building 7, Times Zhirui Technology, 159 Luwu Sanlian Road, Changping Town, DongGuan Guangdong 523578, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dongguan Sheng Yan Industrial Co., Ltd. (Owner Number: 10061894)

Owner / Operator Contact Address

702, 7th Floor, Building 7, Times Zhirui Technology, 159 Luwu Sanlian Road, Changping Town, Dongguan, CN-GD 523578, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cold Pack Nasal Aspirator hand sanitizer Glove nausea band motion sickness bands menstrual cup Halo Menstrual Disc

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2019-11-29
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2021-01-11
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2024-07-08
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	2021-01-11
MVV	Device, Acupressure	Unknown	Class U	N/A	2022-06-30
HHE	Cup, Menstrual	Obstetrics/Gynecology	Class 2	884.5400	2022-05-29

Official Correspondent

Jin Zhu Wu

US Agent Details

FANFEI LIU Email: U.S.agent@frosatechnology.com Phone: (626) 8261385

Related Public Records

Same Entity

Dongguan Sheng Yan Industrial 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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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3003255790	WITKO INCORPORATED	Wolcott, IN, US
3008742818	PT. Hisamitsu Pharma Indonesia	Sidoarjo Jawa Timur, ID

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016195105. Last updated year: 2026. Please use registration number 3016195105 when referencing this establishment in official correspondence.