FDA Registration
Active
🇺🇸 United States
COSMOFRANCE
Reg #: 3007895168
·
FEI: 3007895168
·
Expires 2026
Products
9
Proprietary Names
16
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- COSMOFRANCE
- Registration Number
- 3007895168
- FEI Number
- 3007895168
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2121 SW 3rd Avenue, Suite 500
- City
- Miami
- State
- FL
- ZIP
- 33129
- Country
- US
Regulatory Submissions
- 510(k) Number
- K103736
Owner / Operator
- Firm Name
- COSMOFRANCE
- Operator Number
- 10032329
- Address
- 2121 SW 3rd Avenue, Suite 500
- City
- Miami
- State
- FL
- Postal Code
- 33129
- Country
- US
- Correspondent
- Raphael Dewandre
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2021-11-12 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2020-11-09 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2019-12-24 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2017-05-05 |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | Class 2 | General, Plastic Surgery | No | 2021-10-14 |
| Connector, Catheter | GCD | Class 1 | General, Plastic Surgery | No | 2022-04-18 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2022-06-13 |
| Brush, Dermabrasion, Powered | GFE | Class 1 | General, Plastic Surgery | No | 2014-10-29 |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | Class 1 | Hematology | No | 2017-05-05 |
Proprietary Names
EZSYRINGE
EZSYRINGE BLUE
EZSYRINGE RED
EZSYRINGE WHITE
EZHEAT
EZCOOL
EZINJECT
DERMASCULPT
Novathreads Twist
Novathreads Smooth
EZCONNECTOR
Novathreads Barb
Infinity
Cosmopen
EZPRF
EZGEL
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198