Guangdong Yuehua Medical Instrument Factory Co., Ltd.

Manufacturer and brand owner in Shantou, Guangdong, China. 7 device types, 1 product catalogued.

Registry build 21.09.26

Guangdong Yuehua Medical Instrument Factory Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Adaptor, Hygiene, Cushion, Flotation and 5 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2011.

7device types registered with the FDA
1product

Registration

FDA registration record for Guangdong Yuehua Medical Instrument Factory Co., Ltd.
Registered name GUANGDONG YUEHUA MEDICAL INSTRUMENT FACTORY CO., LTD.
Status Registered
Registration expires 2026
Registration number 3004475699
FEI number 3004475699
DUNS 653842898
Establishment type Contract manufacturer, Manufacturer, Exporter

Chinese Registration

Chinese company register details for Guangdong Yuehua Medical Instrument Factory Co., Ltd.
Chinese legal name 广东粤华医疗器械厂有限公司
Unified social credit code 914405111927222779
Source export sales certificate, Guangdong medical products administration

Location

Address of Guangdong Yuehua Medical Instrument Factory Co., Ltd.
City Shantou
Province Guangdong
Address Rongsheng Science & Technology Zone
Postal code 515063
Country China

What It Makes

Device types Guangdong Yuehua Medical Instrument Factory Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Adaptor, Hygiene Class 1 Shampoo basin 2020 193
Cassette, Radiographic Film Class 2 Cassette 2012 3
Cover, Mattress (Medical Purposes) Class 1 Mattress Cover 2020 89
Cushion, Flotation Class 1 Anti-decubitus Cushion 2019 52
Illuminator, Radiographic-Film Class 1 X-Ray Film Illuminator 2011 5
Mattress, Air Flotation, Alternating Pressure Class 2 Alternating Pressure Mattress 2011 52
Mattress, Flotation Therapy, Non-Powered Class 1 Alternating Pressure Mattress 2020 30

Own-Brand Listings

Devices catalogued by Guangdong Yuehua Medical Instrument Factory Co., Ltd.
Product Code Catalogue numbers
Yhmed FNM 1

Clearances

No clearance names Guangdong Yuehua Medical Instrument Factory Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Guangdong Yuehua Medical Instrument Factory Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K023020 2002-09-26 IXA Traditional Agfa Healthcare Inc.

From the Company

Published by the company on its own website, not by the FDA.

Information published by Guangdong Yuehua Medical Instrument Factory Co., Ltd.
Founded 1969
Factory area 30000 m²
Main products Medical air mattresses, Wheelchair seat cushions, Medical nebulizers, X-ray film cassettes, Medical chart holders
Certifications FDA, CE, CB, RoHS, TUV, ISO 13485, ISO 9001
Export markets International

Nearby Manufacturers

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer