FDA Registration
Active
🇬🇧 United Kingdom
ChitoGauze XR Pro
Reg #: 3011657181
·
FEI: 3011657181
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SAFEGUARD MEDICAL TECHNOLOGIES LTD
- Registration Number
- 3011657181
- FEI Number
- 3011657181
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- The Old Rectory
- City
- Hope Under Dinmore Herefordshire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K153582
Owner / Operator
- Firm Name
- Safeguard US Operating LLC
- Operator Number
- 10048998
- Address
- 13359 Reese Blvd. E
- City
- Huntersville
- State
- NC
- Postal Code
- 28078
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2016-07-01 |
Proprietary Names
ChitoGauze XR Pro
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility