Data / Medical devices / China / Zhejiang Medtec Medical devices Co., Ltd
Zhejiang Medtec Medical devices Co., Ltd: FDA-registered device maker in Hangzhou Zhejiang, China, 1 510(k) clearance
Zhejiang Medtec Medical devices Co., Ltd is registered with the FDA (registration 3007649127) in Hangzhou Zhejiang, China. It lists 10 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 11, 2012. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3007649127
- Address
- No 77 Yangdai Rd Linan Hangzhou, Hangzhou Zhejiang, China, 55364
- Owner or operator
- Zhejiang Medtec Medical devices Co., Ltd (10028750)
- Roles
- Manufacturer
- First device listed
- March 3, 2009
- Registered through
- 2026
- Brand names listed
- Adaptor Universal, Aerosol Mask Elongated, Aerosol Mask Under Lip No Tubing, Aerosol Mask under chin, Anesthetic Mask, CPR barrier, Cannula Flared, Cannula Nonflared and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | 2 | Manufacturer | accessdata.fda.gov |
| Cannula, Nasal, Oxygen | CAT | 1 | Manufacturer | accessdata.fda.gov |
| Catheter, Nasal, Oxygen | BZB | 1 | Manufacturer | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Gas, Anesthetic | BSJ | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Oxygen, Non-Rebreathing | KGB | 1 | Manufacturer | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Manufacturer | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Manufacturer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | 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 |
|---|---|---|---|---|---|---|
| July 11, 2012 | K120424 | MEDSOURCE IV ADMINSTRATION SET | LHI | Substantially Equivalent | Medsource International, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Nasal, Oxygen
- All makers of Cannula, Nasal, Oxygen
- All makers of Mask, Oxygen, Non-Rebreathing
- All makers of Mask, Gas, Anesthetic
- All makers of Mouthpiece, Breathing
- All makers of Catheters, Suction, Tracheobronchial
Updated July 11, 2012. 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.