FDA Registration
Active
🇺🇸 United States
EUSA GLOBAL LLC
Reg #: 3007532396
·
FEI: 3007532396
·
Expires 2026
Products
20
Proprietary Names
61
Establishment Types
4
Classifications
20
Registration Details
- Registration Name
- EUSA GLOBAL LLC
- Registration Number
- 3007532396
- FEI Number
- 3007532396
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 11801 NW 100th Rd Ste 17
- City
- Medley
- State
- FL
- ZIP
- 33178
- Country
- US
Regulatory Submissions
- 510(k) Number
- K100595
Owner / Operator
- Firm Name
- EUSA GLOBAL LLC
- Operator Number
- 10034454
- Address
- 11801 NW 100th Rd, Suite 17
- City
- Medley
- State
- FL
- Postal Code
- 33178
- Country
- US
- Correspondent
- Henry Sand
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Camera, Television, Endoscopic, Without Audio | FWF | Class 1 | General, Plastic Surgery | No | 2011-12-22 |
| Colposcope (And Colpomicroscope) | HEX | Class 2 | Obstetrics/Gynecology | No | 2010-12-02 |
| Brush, Dermabrasion, Powered | GFE | Class 1 | General, Plastic Surgery | No | 2014-04-29 |
| Laryngostroboscope | EQL | Class 1 | Ear, Nose, Throat | No | 2011-12-20 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2014-06-11 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2011-12-09 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2011-12-21 |
| Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | HRM | Class 1 | General, Plastic Surgery | No | 2017-11-02 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2011-12-21 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2014-04-07 |
| Headlamp, Operating, Battery-Operated | HPP | Class 1 | Ophthalmic | No | 2010-12-02 |
| Nystagmograph | GWN | Class 2 | Neurology | No | 2022-09-16 |
| Laryngoscope, Nasopharyngoscope | EQN | Class 2 | Ear, Nose, Throat | No | 2025-01-31 |
| Microscope, Surgical | EPT | Class 1 | General, Plastic Surgery | No | 2011-12-20 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2011-12-22 |
| Laryngoscope, Non-Rigid | CAL | Class 1 | Anesthesiology | No | 2014-03-27 |
| Headlight, Fiberoptic Focusing | FCT | Class 2 | Ophthalmic | No | 2014-12-10 |
| Flowmeter, Calibration, Gas | BXY | Class 1 | Anesthesiology | No | 2024-04-22 |
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2014-12-10 |
| Camera, Television, Microsurgical, Without Audio | FWD | Class 1 | General, Plastic Surgery | No | 2014-04-29 |
Proprietary Names
Procam NTSC
Procam PAL
Procam Basic
Procam HD Basic
Procam HD
Procam
Colposcope C-200F
Colposcope C-200T
Colposcope C100
Colpsocope C-200A
Colposcope C-200W
Minivac EP
Minivac Plus
Minivac
STROBOlight LED
StroboLED
STROBOlight
SN101 SINUSCOPE
PORTALED LED020
PORTALED
Otoscope
2DHD Video Splitter
3DHD Video Splitter
Nasopharyngoscope Flexible
Sinuscope Autoclavable
SN102 SINUSCOPE
Laryngoscope
LaryngoPro R
Geliderm Compact
Geliderm
EP
Shockderm
LED Headlight
LED Headlux
Headlux
VNG Plus
VNG Plus, VNG 3D
FE102: Flexible Nasopharyngoscope
Ecleris MICROSTAR Microscope OM-200W
Ecleris MICROSTAR Microscope OM-200T
Ecleris MICROSTAR Microscope Series
Ecleris MICROSTAR Microscope OM-200C
Ecleris MICROSTAR Microscope OM-200F
Everlux Pro
LED100
Everlux
Everlux Mini
Flex HD
Laryngoscope, FNS-3200, FNS-2800
Headlux Fiberoptics
R-Flowmeter
RM-Flow
LED 100G2/2 Everlux Standard
LED 100G2/1 Everlux Universal
Pico LED
PORTALED USB
Procam FX USB
Procam HD USB
Procam Series
Procam Pack
VI360 PROCAM HD
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198