FDA Registration
Active
🇨🇳 China
Premier Guard Zhongshan Limited
Reg #: 3013046958
·
FEI: 3013046958
·
Expires 2026
Products
10
Proprietary Names
5
Establishment Types
2
Classifications
10
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Registration Details
- Registration Name
- Premier Guard Zhongshan Limited
- Registration Number
- 3013046958
- FEI Number
- 3013046958
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No 52, Huan Mao Yi Road, Torch Development Zone
- City
- Zhongshan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K041501
Owner / Operator
- Firm Name
- Premier Guard Global Limited
- Operator Number
- 9031832
- Address
- 10320 Lake Road, Suite 101
- City
- Houston
- State
- TX
- Postal Code
- 77070
- Country
- US
- Correspondent
- Ross Walker
US Agent
- Business Name
- Premier Guard Global Limited
- Contact Name
- Ross Walker
- Address
- 10320 Lake Rd Ste 101
- City
- Houston
- State
- TX
- ZIP
- 77070
- Country
- US
- [email protected]
- Phone
- 713 8617550
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2006-03-10 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2005-10-12 |
| Retainer, Surgical | GCZ | Class 1 | General, Plastic Surgery | No | 2013-06-06 |
| Cover, Barrier, Protective | MMP | Class 2 | General, Plastic Surgery | No | 2005-07-27 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2007-08-31 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2007-10-19 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2006-03-10 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2019-03-29 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2006-03-10 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2008-01-08 |
Proprietary Names
Retainer, Surgical: RMD3202, 3204, 3206, 3206
Premier Guard Needle Guide
Premier Guard
Face Shield
Ice Bag
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device