FDA Registration
Active
🇺🇸 United States
AMXOR Vital Sterile Lancet fo Single Use
Reg #: 3026197505
·
FEI: 3026197505
·
Expires 2025
Products
2
Proprietary Names
3
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- AMXOR HEALTHCARE LLC
- Registration Number
- 3026197505
- FEI Number
- 3026197505
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1001 Brickell Bay Drive, Suite 2700
- City
- Miami
- State
- FL
- ZIP
- 33131
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222472
Owner / Operator
- Firm Name
- AMXOR Healthcare LLC
- Operator Number
- 10087182
- Address
- 1001 Brickell Bay Drive, Suite 2700
- City
- Miami
- State
- FL
- Postal Code
- 33131
- Country
- US
- Correspondent
- Kiara Tirado
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2024-04-30 |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2024-04-30 |
Proprietary Names
AMXOR Vital Sterile Lancet fo Single Use
AMXOR QuickSafe Lancing Device
AMXOR QuickSafe Lancing System
Establishment Types
Repack or Relabel Medical Device