Alleva Medical (D.G.) Ltd
Registered establishment in Dongguan, Guangdong, China. 13 device types, 1 clearance.
Alleva Medical (D.G.) Ltd is a contract manufacturer holding a current FDA establishment registration. The registration covers Accessories, Catheter, Pump, Breast, Powered and 11 other device types. Its earliest product listing with the FDA dates from 2014.
Registration
| Registered name | ALLEVA MEDICAL (D.G.) LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010308146 |
| FEI number | 3010308146 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Dongguan |
|---|---|
| Province | Guangdong |
| Address | 76 San Lian Nan Road, Lu Wu Administration District, |
| Postal code | 523587 |
| Country | China |
What It Makes
Clearances
1 clearance names Alleva Medical (D.G.) Ltd as applicant. 6 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 |
|---|---|---|---|---|
| K191107 | 2019-08-27 | JOW | Traditional | This company |
| K213906 | 2023-03-08 | OMP | Traditional | Alleva Medical Ltd |
| K143362 | 2015-02-03 | OMP | Special | Devon Medical Products |
| K140634 | 2014-09-19 | OMP | Traditional | Devon Medical, Inc. |
| K132225 | 2014-05-15 | OMP | Traditional | Devon Medical, Inc. |
| K132252 | 2013-09-27 | OMP | Special | Devon Medical, Inc. |
| K110078 | 2012-02-10 | OMP | Traditional | Devon Medical Products |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2005 |
|---|---|
| Factory area | 500,000 square feet |
| Main products | Medical devices, Healthcare products, Disposable medical consumables, Surgical accessories, Compression medical devices |
| Certifications | FDA, CFDA, ISO 13485, ISO 9001 |
| Export markets | North America, Europe, Japan, China |
| 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.