Data / Medical devices / China / Qinhuangdao Taizhi Medical Technology Co., Ltd
Qinhuangdao Taizhi Medical Technology Co., Ltd: FDA-registered device maker in Qinhuangdao Hebei, China, 3 510(k) clearances
Qinhuangdao Taizhi Medical Technology Co., Ltd is registered with the FDA (registration 3016948452) in Qinhuangdao Hebei, China. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 7, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3016948452
- Address
- Workshop 5, small and medium-sized enterprise incubation base, East Longgang Road, Haigang District, Qinhuangdao Hebei, China, 066000
- Owner or operator
- Qinhuangdao Taizhi Medical Technology Co., Ltd (10066128)
- Roles
- Manufacturer
- First device listed
- April 1, 2020
- Registered through
- 2026
- Brand names listed
- Disposable Surgical Mask (Non Sterile), Face mask per enforcement policy for face masks and respirators during the declared public health emergency, MASK, SCAVENGING, Medical Protective Masks, Respirator, surgical, Shield, protective, personnel
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Manufacturer | accessdata.fda.gov |
| Mask, Scavenging | KHA | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Manufacturer | accessdata.fda.gov |
| Shield, Protective, Personnel | KPY | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 7, 2023 | K223686 | Medical Protective Masks | FXX | Substantially Equivalent | Qinhuangdao Taizhi Medical Technology Co., Ltd. | accessdata.fda.gov |
| October 14, 2021 | K212205 | Medical Protective Masks | FXX | Substantially Equivalent | Qinhuangdao Taizhi Medical Technology Co., Ltd. | accessdata.fda.gov |
| August 25, 2021 | K211451 | Disposable Surgical Mask (non sterile) | FXX | Substantially Equivalent | Qinhuangdao Taizhi Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Respirator, Surgical
- All makers of Mask, Surgical
- All makers of Shield, Protective, Personnel
- All makers of Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- All makers of Mask, Scavenging
Updated February 7, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.