Caire Medical Technology (Chengdu) Co., Ltd.
Registered establishment in Chengdu, Sichuan, China. 1 device type.
Caire Medical Technology (Chengdu) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Generator, Oxygen, Portable. Its earliest product listing with the FDA dates from 2011.
Registration
| Registered name | CAIRE Medical Technology (Chengdu) Co., Ltd. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009550619 |
| FEI number | 3009550619 |
| Establishment type | Manufacturer |
Location
| City | Chengdu |
|---|---|
| Province | Sichuan |
| Address | 1/F, Building 4, No. 670 Haifa Road |
| Postal code | 611138 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Generator, Oxygen, Portable | Class 2 | Eclipse Oxygen System, Multiple, VisionAire 5, VisionAire 3, VisionAire V, NewLife Elite, VisionAire 2 and 1 more | 2011 | 22 |
Clearances
No clearance names Caire Medical Technology (Chengdu) Co., Ltd. as applicant. 2 are held by other companies 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 |
|---|---|---|---|---|
| K013931 | 2002-03-27 | CAW | Traditional | Sequal Technologies, Inc. |
| K872534 | 1987-10-13 | CAW | Traditional | Airsep Corp. |
From the Company
Published by the company on its own website, not by the FDA.
| Employees | 86 |
|---|---|
| Factory area | 4,553 square meters (49,013 square feet) |
| Main products | Newlife Intensity 10 (stationary oxygen concentrator), Freestyle Comfort (portable molecular sieve concentrator), VisionAire (portable stationary concentrator), Eclipse 5 (multifunctional portable oxygen concentrator) |
| Certifications | US FAA certification for portable oxygen concentrators, Internet pharmaceutical information service qualification certificate |
| Export markets | United States, Japan, Asia-Pacific region |
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.