Zhejiang Medtec Medical Devices Co., Ltd.
Registered establishment in Hangzhou, Zhejiang, China. 10 device types.
Zhejiang Medtec Medical devices Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Mask, Oxygen, Mask, Gas, Anesthetic and 8 other device types. Its earliest product listing with the FDA dates from 2009.
Registration
| Registered name | Zhejiang Medtec Medical devices Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007649127 |
| FEI number | 3007649127 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 浙江美迪泰医疗器械有限公司 |
|---|---|
| Unified social credit code | 91330185MA2CD6T03Q |
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | No 77 Yangdai Rd |
| Postal code | 55364 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | Class 2 | Yankaeur Tip & Tube, Non-Vented, Yankaeur Tube only, Vented, Yankaeur Tip only, Non-Vented, Yankaeur Tube only, Yankaeur Tip & Tube, Vented, Yankaeur Tip only, Vented | 2009 | 30 |
| Cannula, Nasal, Oxygen | Class 1 | Soft Cannula, Cannula Flared, Nasal Cannula Nonflared, Nasal Cannula Flared, Nasal Cannula, Nasal Cannula Tubing and 9 more | 2009 | 97 |
| Catheter, Nasal, Oxygen | Class 1 | Catheter | 2010 | 14 |
| Catheters, Suction, Tracheobronchial | Class 1 | Manual Suction Pump, Suction Catheter, Manual Section Pump refill Cannister | 2009 | 93 |
| Mask, Gas, Anesthetic | Class 1 | Anesthetic Mask | 2020 | 71 |
| Mask, Oxygen | Class 1 | Oxygen Mask U. Conn., Tracheostomy Mask No tubing, Venturi Mask Kit All Diluters, Oxygen Mask Elongated, Aerosol Mask under chin, Aerosol Mask Under Lip No Tubing and 3 more | 2012 | 126 |
| Mask, Oxygen, Non-Rebreathing | Class 1 | Tee Aerosol, High Concentrate NRB Mask, Curaplex Total Non-Rebreather, Non-Rebreather with vent, Mask Oxygen, Nonrebreather, Non-Rebreather and 2 more | 2009 | 72 |
| Mouthpiece, Breathing | Class 1 | CPR barrier | 2026 | 67 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Class 1 | Nebulizer with mask, Nebulizer without mask, Nebulizer hand held | 2009 | 57 |
| Set, I.V. Fluid Transfer | Class 2 | MedSource I.V. Administration Set | 2013 | 8 |
Clearances
No clearance names Zhejiang Medtec Medical devices Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K120424 | 2012-07-11 | LHI | Traditional | Medsource International, LLC |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1989 |
|---|---|
| Employees | 120 |
| Factory area | 13,554 m² |
| Main products | Nasal cannula, Oxygen masks, Nebulizer masks, Suction catheters, Yankauer tips |
| Certifications | ISO 13485, FDA, GMP, CE, QSR820 |
| Export markets | International (multilingual site: Portuguese, German, French, Russian, Italian, Japanese, Arabic, Spanish) |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.