This page includes the latest FDA filings for Watmind Usa. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Watmind Usa holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 0 | ||||||||||
| FEI Number | 0 | ||||||||||
| Name | Shenzhen Watmind Medical Co., Ltd. | ||||||||||
| Owner & Operator | Watmind USA | ||||||||||
| Contact Address | 2802 Flintrock Trace Suite 359 Austin TX 78738 US | ||||||||||
| Official Correspondent |
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| US Agent |
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| Importing Logistics Registration |
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| Registration Status | 5 | ||||||||||
| Initial Importer | N | ||||||||||
| Registration Expiration | 2020-04-25 | ||||||||||
| Registration Address | 8th Floor, Building A, No. 16-1, Jinhui Road, Jinsha Community, Pingshan District, Shenzhen, China Shenzhen Guangdong, 518118 CN | ||||||||||
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| WatMIND USA | Speedy Swab Rapid COVID-19 & FLU A&B Self-Test | 2024-09-09 |
| WatMIND USA | Speedy Swab Rapid COVID-19 & FLU A&B Self-Test | 2024-09-09 |
| WatMIND USA | CARTON-RDB1V10-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Test (1 Test/Box) | 2024-08-16 |
| WatMIND USA | CARTON-RDB2V6-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Test (2 Tests/Box) | 2024-08-16 |
| WatMIND USA | CARTON-RDB1V10-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Test (1 Test/Box) | 2024-08-16 |
| WatMIND USA | CARTON-RDB2V6-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Test (2 Tests/Box) | 2024-08-16 |
| WatMIND USA | RDB10-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test | 2024-08-16 |
| WatMIND USA | RDB6-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box) | 2024-08-16 |
| WatMIND USA | RDB10-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (1 Test/Box) | 2024-08-16 |
| WatMIND USA | RDB6-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box) | 2024-08-16 |
| WatMIND USA | Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (1 Test/Box) | 2024-08-16 |
| WatMIND USA | Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box) | 2024-08-16 |
| WatMIND USA | Speedy Swab Rapid COVID-19 & FLU A+B (4 Tests/Box) | 2024-08-16 |
| WatMIND USA | CASE SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 25 Tests/Box | 2024-07-18 |
| WatMIND USA | CASE SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box | 2024-07-18 |
| WatMIND USA | CASE-RDB-SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box | 2024-07-18 |
| WatMIND USA | CASE-RDB-SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 2 Tests/Box | 2024-07-18 |
| WatMIND USA | CASE SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 4 Tests/Box | 2024-07-18 |
| WatMIND USA | CASE SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 2 Tests/Box | 2024-07-18 |
| WatMIND USA | Retail Display Box - SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Tes | 2024-07-18 |
| WatMIND USA | Retail Display Box - SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 2 Tes | 2024-07-18 |
| WatMIND USA | SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 25 Tests/Box | 2024-07-18 |
| WatMIND USA | SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 4 Tests/Box | 2024-07-18 |
| WatMIND USA | SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 2 Tests/Box | 2024-07-18 |
| WatMIND USA | SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box | 2024-07-18 |
Shenzhen Watmind Medical Co., Ltd. [Watmind USA] | Shenzhen Watmind MF05 Compact Microfluidic Chemiluminescence Analyzer | 2020-04-15 |
Shenzhen Watmind Medical Co., Ltd. [Watmind USA] | Shenzhen Watmind MF02 Hand Carriable Microfluidic Chemiluminescence Analyzer | 2020-04-15 |
Shenzhen Watmind Medical Co., Ltd. [Watmind USA] | Shenzhen Watmind SARS-CoV-2 IgM Microfluidic Reagent Chip | 2020-04-09 |
Shenzhen Watmind Medical Co., Ltd. [Watmind USA] | Shenzhen Watmind SARS-CoV-2 IgG Microfluidic Reagent Chip | 2020-04-09 |
Shenzhen Watmind Medical Co., Ltd. [Watmind USA] | Shenzhen Watmind SARS-CoV-2 Ag Microfluidic Reagent Chip | 2020-04-09 |
Shenzhen Watmind Medical Co., Ltd. [Watmind USA] | Shenzhen Watmind SARS-CoV-2 Ab Microfluidic Reagent Chip | 2020-04-09 |
Shenzhen Watmind Medical Co., Ltd. [Watmind USA] | Shenzhen Watmind Medical Co. SARS-CoV-2 IgG/IgM Ab Diagnostic Test Kit | 2020-04-09 |