FDA Registration
Active
🇮🇱 Israel
B.Y. MEDIMOR LTD
Reg #: 3011782009
·
FEI: 3010666513
·
Expires 2026
Products
16
Proprietary Names
22
Establishment Types
2
Classifications
16
Registration Details
- Registration Name
- B.Y. MEDIMOR LTD
- Registration Number
- 3011782009
- FEI Number
- 3010666513
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Tsivonit St. 1
- City
- Tiberias Northern
- Country
- IL
Regulatory Submissions
- 510(k) Number
- DEN210052
Owner / Operator
- Firm Name
- B.Y. Medimor Ltd
- Operator Number
- 10049471
- Address
- Tsivonit St. 1, P.O. Box 89
- City
- Tiberias
- State
- IL-NOTA
- Postal Code
- 1410002
- Country
- IL
- Correspondent
- Marta Lino
US Agent
- Business Name
- EVERSANA Life Science Services
- Contact Name
- Kory Dillman
- Address
- 7045 College Blvd., Suite 300
- City
- Overland Park
- State
- KS
- ZIP
- 66211
- Country
- US
- [email protected]
- Phone
- 816 6457164
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2022-12-20 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2022-12-20 |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | Class 2 | General, Plastic Surgery | No | 2022-12-20 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2022-12-20 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2022-12-20 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2023-05-10 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2022-12-20 |
| Massager, Vacuum, Light Induced Heating | NUV | Class 2 | General, Plastic Surgery | No | 2022-12-20 |
| Adjunctive Pain Measurement Device For Anesthesiology | QVE | Class 2 | Anesthesiology | No | 2023-12-11 |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | Class 2 | General, Plastic Surgery | No | 2022-12-20 |
| Orally Ingested Transient Device For Constipation | QTN | Class 2 | Gastroenterology, Urology | No | 2023-01-06 |
| Anti Fog Solution And Accessories, Endoscopy | OCT | Class 2 | Gastroenterology, Urology | No | 2023-04-18 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2023-04-18 |
| Ventilatory Effort Recorder | MNR | Class 2 | Anesthesiology | No | 2025-04-30 |
| Amplifier, Physiological Signal | GWL | Class 2 | Neurology | No | 2025-04-30 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2025-04-30 |
Proprietary Names
InMode System with Tone Applicator
EmFace Device
InMode Diolaze System
InMode System with Fractora3D/3D-90 Applicators
PathKeeper System
InMode RF Multi-System
InMode PLUS System
Syneron CO2RE System
FRACTORA
InMode RF Pro System
InMode System MiniFX Handpiece
PMD-200
InMode Multi-system
Vibrant System
InMode FRF Applicator
Plasma Shield
DormoTech NLab
INMODE WMBODY DEVICE
Evolve System with the Tone Applicator
InMode RF System
INMODE WMFACE DEVICE
InMode Plus System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device