FDA 510(k) Applications Submitted by Zearou Yang
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K210059 |
01/11/2021 |
Promisemed Insulin Pen Needle |
Promisemed Hangzhou Meditech Co., Ltd. |
| K210065 |
01/11/2021 |
Verifine Safety Type Insulin Pen Needle |
Promisemed Hangzhou Meditech Co., Ltd. |
| K220129 |
01/18/2022 |
Promisemed X-Safety Pen Needle |
Promisemed Hangzhou Meditech Co., Ltd. |
| K210712 |
03/10/2021 |
Verifine Mechanical Safety Insulin Syringe |
Promisemed Hangzhou Meditech Co., Ltd. |
| K230715 |
03/15/2023 |
Promisemed Safety Huber Needle |
Promisemed Hangzhou Meditech Co., Ltd. |
| K210946 |
03/30/2021 |
Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles |
Promisemed Hangzhou Meditech Co., Ltd. |
| K211242 |
04/26/2021 |
Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes |
Promisemed Hangzhou Meditech Co., Ltd. |
| K211293 |
04/26/2021 |
Safety Winged Blood Collection Sets |
Promisemed Hangzhou Meditech Co., Ltd. |
| K221368 |
05/12/2022 |
Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet |
Promisemed Hangzhou Meditech Co., Ltd. |
| K221371 |
05/12/2022 |
Promisemed Heel Blood Lancet |
Promisemed Hangzhou Meditech Co., Ltd. |
| K231792 |
06/20/2023 |
VeriSafe Safety sterile syringes |
Promisemed Hangzhou Meditech Co., Ltd. |
| K211890 |
06/21/2021 |
Promisemed Sharps container |
Promisemed Hangzhou Meditech Co., Ltd. |
| K191853 |
07/10/2019 |
Dual-Safety Pen Needle |
Promisemed Hangzhou Meditech Co., Ltd. |
| K222271 |
07/29/2022 |
Verisafe Safety sterile needles |
Promisemed Hangzhou Meditech Co., Ltd. |
| K202681 |
09/15/2020 |
Promisemed Covered Safety Pen Needle |
Promisemed Hangzhou Meditech Co., Ltd. |
| K202682 |
09/15/2020 |
Promisemed Triple Safety Pen Needle |
Promisemed Hangzhou Meditech Co., Ltd. |
| K192666 |
09/25/2019 |
Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet |
Promisemed Hangzhou Meditech Co., Ltd. |
| K193009 |
10/28/2019 |
Promisemed Heel Blood Lancet |
Promisemed Hangzhou Meditech Co., Ltd. |
| K213560 |
11/09/2021 |
Verifine Safety Syringe with Fixed Needle |
Promisemed Hangzhou Meditech Co., Ltd. |
| K223453 |
11/16/2022 |
Insulin Syringe |
Promisemed Hangzhou Meditech Co., Ltd. |
| K213683 |
11/22/2021 |
Promisemed Fine Biopsy Needle |
Promisemed Hangzhou Meditech Co., Ltd. |
| K223643 |
12/06/2022 |
Verifine« Ease Lancing Device, Verifine« Lancing Device |
Promisemed Hangzhou Meditech Co., Ltd. |
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