FDA Registration
Active
🇺🇸 United States
Infinity Medical International LLC
Reg #: 3037966040
·
FEI: 3037966040
·
Expires 2026
Products
6
Proprietary Names
6
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- Infinity Medical International LLC
- Registration Number
- 3037966040
- FEI Number
- 3037966040
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 245 Se 1st St Ste 214
- City
- Miami
- State
- FL
- ZIP
- 33131
- Country
- US
Regulatory Submissions
- 510(k) Number
- K251303
Owner / Operator
- Firm Name
- infinity medical
- Operator Number
- 10093099
- Address
- 245 se 1st street, 214
- City
- Miami
- State
- FL
- Postal Code
- 33131
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2026-03-03 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2026-03-25 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2026-03-02 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2026-03-03 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2026-03-02 |
| Resectoscope | FJL | Class 2 | Gastroenterology, Urology | No | 2026-03-02 |
Proprietary Names
MEDF1RST RIGID CYSTOSCOPE: MF027190CP MF04302C MF1227190CP MF124302C MF3027190CP MF304302C MF7027190CP MF704302C
Thulium laser 60w
Medf1rst needle holder
SEMI RIGID URETEROSCOPE MEDF1RST: MF430.4.5.1C MF430.6.1C MF430.6.2C MF430.8.1C MF430.8.2C
Medf1rst laparoscopic instruments
Hybrid medf1rst resectoscope and accessories
Establishment Types
Manufacture Device in the United States for Export Only
Repack or Relabel Medical Device