Data / Medical devices / China / Tianjin Medis Medical Device Co., Ltd.
Tianjin Medis Medical Device Co., Ltd.: FDA-registered device maker in Tianjin, Tianjin, China, 2 510(k) clearances
Tianjin Medis Medical Device Co., Ltd. is registered with the FDA (registration 3004992992) in Tianjin, Tianjin, China. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 25, 2019. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004992992
- Address
- No.15-A, Saida One Avenue Xiqing Economic Development Area, Tianjin, Tianjin, China, 300385
- Owner or operator
- TIANJIN MEDIS MEDICAL DEVICE CO., LTD. (9070069)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- February 3, 2005
- Registered through
- 2026
- Brand names listed
- 100% Silicone Laryngeal mask, Accucuff Cuff Pressure Indicator, DYNJAFLEX25~100, DYNJAFLEXU20~65, Disposable Endotracheal Tube, Sterile Accu CuffTM, Endotracheal Tube Introducer (Bougie), Flowguard Laryngeal Mask, Laryngeal mask, Silicone/PVC and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Airway, Nasopharyngeal | BTQ | 1 | Manufacturer | accessdata.fda.gov |
| Airway, Oropharyngeal, Anesthesiology | CAE | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Cuff, Tracheal Tube, Inflatable | BSK | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Stylet, Tracheal Tube | BSR | 1 | Contract manufacturer | accessdata.fda.gov |
| Tube, Tracheal (W/Wo Connector) | BTR | 2 | Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| January 25, 2019 | K182548 | Accucuff Cuff Pressure Indicator | BSK | Substantially Equivalent | Tianjin Medis Medical Device Co., Ltd. | accessdata.fda.gov |
| April 7, 2017 | K160694 | Disposable Endotracheal tube, sterile, AccuCuff | BTR | Substantially Equivalent | Tianjin Medis Medical Device Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Cuff, Tracheal Tube, Inflatable
- All makers of Tube, Tracheal (W/Wo Connector)
- All makers of Airway, Oropharyngeal, Anesthesiology
- All makers of Airway, Nasopharyngeal
- All makers of Stylet, Tracheal Tube
Updated January 25, 2019. 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.