Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004475699

FEI Number

3004475699

Entity Name

GUANGDONG YUEHUA MEDICAL INSTRUMENT FACTORY CO., LTD.

City/State/Country

Shantou Guangdong, CN

Establishment Address

Rongsheng Science & Technology Zone, Daxue Rd., Shantou Guangdong 515063, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Guangdong Yuehua Medical Instrument Factory Co., Ltd. (Owner Number: 10039189)

Owner / Operator Contact Address

Rongsheng Science & Technology Zone, Daxue Rd., Shantou, CN-GD 515063, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Shampoo basin Anti-decubitus Cushion X-Ray Film Illuminator Mattress Cover Cassette Alternating Pressure Mattress

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2020-12-08
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2019-12-30
IXC	Illuminator, Radiographic-Film	Radiology	Class 1	892.1890	2011-12-15
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2020-12-08
IXA	Cassette, Radiographic Film	Radiology	Class 2	892.1850	2012-01-17
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2020-12-08

Official Correspondent

Su Zhaosheng

US Agent Details

Qihui Zhang Business: ZYPPEL LLC Email: Qzhang@Zyppel.Com Phone: (617) 2991655

Related Public Records

Same Entity

Guangdong Yuehua Medical Instrument Factory 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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004475699. Last updated year: 2026. Please use registration number 3004475699 when referencing this establishment in official correspondence.