Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043128348

FEI Number

3043128348

Entity Name

Shenzhen Yang Biotech Co., Ltd.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

No. 315, Shuangming Avenue, Dongzhou Community, Guangming Street, Guangming District, Shenzhen Guangdong 518107, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Watmind USA (Owner Number: 10068643)

Owner / Operator Contact Address

4780 I 55 N Frontage Rd., Suite 450, Jackson, MS 39211, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test Speedy Swab Rapid COVID-19 Antigen Self-Test Speedy Swab Rapid COVID-19 + Flu A&B Antigen Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2020-04-15

Official Correspondent

Kyle Rose

US Agent Details

Anna Edwards Email: mike@watmindusa.com Phone: (713) 4176387

Related Public Records

Same Entity

Watmind USA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016761091	Shenzhen Watmind Medical Co., Ltd.	Shenzhen Guangdong, CN
3021082896	WATMIND USA	Jackson, MS, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2023	Jiangsu Well Biotech Co., Ltd. No	N	Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

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3008054239	CORE TECHNOLOGY CO., LTD.	Changping District Beijing, CN
3016761091	Shenzhen Watmind Medical Co., Ltd.	Shenzhen Guangdong, CN
3002642396	Ortho Clinical Diagnostics	Singapore South West, SG
3023947183	iHealth Manufacturing Inc	Irwindale, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043128348. Last updated year: 2026. Please use registration number 3043128348 when referencing this establishment in official correspondence.