Premier Guard Zhongshan Limited
Registered establishment in Zhongshan, Guangdong, China. 10 device types.
Premier Guard Zhongshan Limited is a contract manufacturer holding a current FDA establishment registration. The registration covers Clamp, Bag, Ice and 8 other device types. Its earliest product listing with the FDA dates from 2005.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3013046958 |
| FEI number | 3013046958 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 派瑞嘉德(中山)医疗用品有限公司 |
|---|---|
| Unified social credit code | 91442000MA4ULN3595 |
| Source | provincial manufacturer licence lists |
Location
| City | Zhongshan |
|---|---|
| Province | Guangdong |
| Address | No 52, Huan Mao Yi Road |
| Postal code | 528400 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Face Shield | 2006 | 439 |
| Bag, Ice | Class 1 | Ice Bag | 2008 | 86 |
| Clamp | Class 1 | Premier Guard | 2007 | 24 |
| Cover, Barrier, Protective | Class 2 | 2005 | 15 | |
| Guide, Needle, Surgical | Class 1 | Premier Guard Needle Guide | 2007 | 32 |
| Instrument, Manual, Surgical, General Use | Class 1 | 2019 | 110 | |
| Orthosis, Limb Brace | Class 1 | 2005 | 144 | |
| Protector, Skin Pressure | Class 1 | 2006 | 101 | |
| Retainer, Surgical | Class 1 | Retainer, Surgical: RMD3202, 3204, 3206, 3206 | 2013 | 10 |
| Walker, Mechanical | Class 1 | 2006 | 183 |
Clearances
No clearance names Premier Guard Zhongshan Limited 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 |
|---|---|---|---|---|
| K041501 | 2004-11-30 | MMP | Traditional | Guangzhou Fortunique, Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2016 |
|---|---|
| Main products | Surgical gloves, Face masks, Surgical gowns, Medical protective equipment |
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.