FDA Registration
Active
🇬🇧 United Kingdom
SAFEGUARD MEDICAL TECHNOLOGIES LTD
Reg #: 3011657181
·
FEI: 3011657181
·
Expires 2026
Products
11
Proprietary Names
14
Establishment Types
2
Classifications
11
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Registration Details
- Registration Name
- SAFEGUARD MEDICAL TECHNOLOGIES LTD
- Registration Number
- 3011657181
- FEI Number
- 3011657181
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Unit G Moreton Business Park, Moreton-On-Lugg
- City
- Hereford 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 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2015-03-30 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2025-09-22 |
| Needle, Catheter | GCB | Class 1 | General, Plastic Surgery | No | 2015-03-30 |
| Stretcher, Hand-Carried | FPP | Class 1 | General Hospital | No | 2024-03-26 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2020-11-25 |
| Belt, Pelvic, Traction | HSQ | Class 1 | Orthopedic | No | 2020-11-25 |
| Splint, Traction | HSP | Class 1 | Orthopedic | No | 2015-03-30 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2020-11-25 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2019-12-06 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2020-11-25 |
Proprietary Names
ChitoGauze XR Pro
Steady-Head
Nasal Airway
Russell PneumoFix
Russell PneumoFix-8
Safeguard
OmniSplint
Pelvic Splint
Prometheus Traction Splint
SelfSAVE kit
FullStop
TMT
SWAT-T
Russell Chest Seal
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device