Guangdong Youkey Medical Co., Ltd.

Manufacturer and brand owner in Foshan, Guangdong, China. 3 device types, 1 product catalogued, 2 clearances.

Registry build 21.09.26

Guangdong Youkey Medical Co., Ltd. is a complaint-file establishment holding a current FDA establishment registration. The registration covers Transducer, Ultrasonic, Diagnostic, System, Imaging, Pulsed Echo, Ultrasonic and 1 other device type. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2022.

3device types registered with the FDA
1product
2510(k) clearances

Registration

FDA registration record for Guangdong Youkey Medical Co., Ltd.
Registered name GUANGDONG YOUKEY MEDICAL CO., LTD.
Status Registered
Registration expires 2026
Registration number 3025429169
FEI number 3025429169
DUNS 714951617
Establishment type Complaint-file establishment, Manufacturer

Chinese Registration

Chinese company register details for Guangdong Youkey Medical Co., Ltd.
Chinese legal name 广东启佑医疗有限公司
Unified social credit code 91440605MA54PCJ42U
Source export sales certificate, Guangdong medical products administration

Location

Address of Guangdong Youkey Medical Co., Ltd.
City Foshan
Province Guangdong
Address Unit 601, Block B, Building 1, B1 District, Hantian Technology City, Nanhai District
Postal code 528203
Country China

What It Makes

Device types Guangdong Youkey Medical Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
System, Imaging, Pulsed Doppler, Ultrasonic Class 2 Digital Ultrasonic Diagnostic Imaging System (Model: F6), Pocket Ultrasound System (model: P50, P51, P52, P53, P54, P55, P56) 2022 22
System, Imaging, Pulsed Echo, Ultrasonic Class 2 Digital Ultrasonic Diagnostic Imaging System (Model: F6), Pocket Ultrasound System (model: P50, P51, P52, P53, P54, P55, P56) 2022 37
Transducer, Ultrasonic, Diagnostic Class 2 Digital Ultrasonic Diagnostic Imaging System (Model: F6), Pocket Ultrasound System (model: P50, P51, P52, P53, P54, P55, P56) 2022 44

Own-Brand Listings

Devices catalogued by Guangdong Youkey Medical Co., Ltd.
Product Code Catalogue numbers
Transducer, Ultrasonic, Diagnostic ITX 7

Clearances

510(k) clearances naming Guangdong Youkey Medical Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K231930 2024-03-22 IYN Traditional This company
K211746 2022-02-18 IYN Traditional This company

From the Company

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

Information published by Guangdong Youkey Medical Co., Ltd.
Founded 2015
Employees 51-200
Main products Wireless portable handheld ultrasound, Soloscan ultrasound, D8 ultrasound, F6 ultrasound
Certifications CE, FDA, CFDA, ANVISA, ISO13485, MDSAP
Export markets Over 100 countries

Nearby Manufacturers

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Manufacturer Device types
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Foshan Jindi Electric Appliance Co., Ltd. 1
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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.

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