Ningbo Besmed Medical Equipment Corp.
Registered establishment in Ningbo, Zhejiang, China. 13 device types.
Ningbo Besmed Medical Equipment Corp. is a manufacturer holding a current FDA establishment registration. The registration covers Mask, Oxygen, Mask, Gas, Anesthetic and 11 other device types. Its earliest product listing with the FDA dates from 2007.
Registration
| Registered name | NINGBO BESMED MEDICAL EQUIPMENT CORP. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006547005 |
| FEI number | 3006547005 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 宁波贝斯美德医用器械有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Ningbo |
|---|---|
| Province | Zhejiang |
| Address | NO.51, MO GAN SHAN RD, BEILUN |
| Postal code | 315800 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Airway, Oropharyngeal, Anesthesiology | Class 1 | Laryngeal Airway Mask, Guedel Airway, Besmed Berman | 2007 | 84 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class 2 | Besmed CO2 Monitoring Line With and Without In-Line Filter, Besmed CO2 Monitoring Line W/Nasal Cannula | 2015 | 29 |
| Cannula, Nasal, Oxygen | Class 1 | NCPAP Nasal Cannula, NCAT™ Nasal Cannula, Nasal prong, interface of Nasal CPAP, iNFLOW™, Hi-iNFLOW™ and 2 more | 2007 | 97 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | Class 1 | T-piece, Mask (Size 00, 000), Manometer, Infant, Manifold Exhalation Valve (CT-11450), Manifold Exhalation Valve (CT-11470), T-piece, Mask (Size 00, 000), Infant, T-piece, Manifold Exhalation Valve (CT-11420) and 2 more | 2007 | 55 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | Class 1 | Besmed Humidifier | 2007 | 55 |
| Mask, Gas, Anesthetic | Class 1 | Besmed AIR Cushion Mask, AIR Cushion Mask, Besmed Silicone | 2007 | 71 |
| Mask, Oxygen | Class 1 | Soft Tracheostomy Mask, , Oxygen, Aerosol, Silicone Mask, Besmed Face Tent, Besmed Oxygen Mask and 1 more | 2007 | 126 |
| Mask, Oxygen, Non-Rebreathing | Class 1 | Besmed CRR Pocket Mask, Besmed HI-Oxygen Mask | 2007 | 72 |
| Mouthpiece, Breathing | Class 1 | Besmed Mouthpiece, Besmed Bite Block, Mouthpiece | 2007 | 67 |
| Nebulizer (Direct Patient Interface) | Class 2 | Besmed Reusable Jet Nebulizer, Besmed Jet Nebulizer Bottle Set | 2010 | 42 |
| Set, Tubing And Support, Ventilator (W Harness) | Class 1 | Besmed Valved Tee Adapter, NCPAP Circuit, Neonatal Circuit | 2014 | 33 |
| Strap, Head, Gas Mask | Class 1 | Bonnet, Nasal mask, Besmed Head Strap | 2007 | 29 |
| Tubing, Pressure And Accessories | Class 1 | Besmed Oxygen Tubing | 2007 | 45 |
Clearances
No clearance names Ningbo Besmed Medical Equipment Corp. as applicant. 3 are 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 |
|---|---|---|---|---|
| K150591 | 2015-06-30 | CAF | Traditional | Besmed Health Business Corporation |
| K143150 | 2015-02-05 | CCK | Traditional | Besmed Health Business Corporation |
| K091272 | 2009-11-10 | CAF | Traditional | Besmed Health Business Corporation |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1998 |
|---|---|
| Main products | manual resuscitators, face masks, airway management, oxygen therapy, nebulizer equipment |
| Certifications | ISO 13485, FDA, QMS, CE, GMP, ISO 9001 |
| Export markets | 60+ countries |
| OEM and ODM | Offered |
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.