Heyuan Hong DE Medical Products Co., Ltd.

Registered establishment in Heyuan, Guangdong, China. 13 device types.

Registry build 21.09.26

Heyuan Hong DE Medical Products Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Basin, Emesis, Gown, Surgical and 11 other device types. Its earliest product listing with the FDA dates from 2016.

Registration

FDA registration record for Heyuan Hong DE Medical Products Co., Ltd.
Registered name HEYUAN HONG DE MEDICAL PRODUCTS CO., LTD.
Status Registered
Registration expires 2026
Registration number 3013429557
FEI number 3013429557
Establishment type Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter

Chinese Registration

Chinese company register details for Heyuan Hong DE Medical Products Co., Ltd.
Chinese legal name 河源市鸿德医疗用品有限公司
Source customs registration record

Location

Address of Heyuan Hong DE Medical Products Co., Ltd.
City Heyuan
Province Guangdong
Address 3rd Road Linjiang Industrial Zone
Postal code 517001
Country China

What It Makes

Device types Heyuan Hong DE Medical Products Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Basin, Emesis Class 1 2017 65
Blood Pressure Cuff Class 2 2016 50
Collector, Urine, (And Accessories) For Indwelling Catheter Class 2 2016 51
Cover, Barrier, Protective Class 2 2016 15
Cover, Shoe, Operating-Room Class 1 2016 176
Drape, Surgical, Antimicrobial Class 2 2016 39
Drape, Surgical, Exempt Class 2 2017 107
Gown, Surgical Class 2 2016 68
Instrument, Manual, Surgical, General Use Class 1 2016 110
Light, Surgical, Accessories Class 2 2023 21
Non-Surgical Gown Class 1 2016 318
Support, Patient Position Class 1 2023 66
Transducer, Ultrasonic, Diagnostic Class 2 Cover Probe W/GEL & Bands 2024 44

Clearances

No clearance names Heyuan Hong DE Medical Products 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 Heyuan Hong DE Medical Products Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K221278 2023-01-11 ITX Traditional Hony Medical Co., Ltd.

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