FDA Registration
Active
🇮🇱 Israel
TYTOCARE LTD.
Reg #: 3012678246
·
FEI: 3012678246
·
Expires 2026
Products
8
Proprietary Names
6
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- TYTOCARE LTD.
- Registration Number
- 3012678246
- FEI Number
- 3012678246
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 14 Beni Gaon St.
- City
- Netanya Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K232237
Owner / Operator
- Firm Name
- Tytocare Ltd.
- Operator Number
- 10052860
- Address
- 14 Beni Gaon St.
- City
- Netanya
- State
- IL-NOTA
- Postal Code
- 4250803
- Country
- IL
- Correspondent
- Stella Raizelman Perry
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2016-10-13 |
| Abnormal Breath Sound Device | PHZ | Class 2 | Anesthesiology | No | 2023-12-19 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2016-10-13 |
| Stethoscope, Electronic | DQD | Class 2 | Cardiovascular | No | 2016-10-26 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2019-04-04 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2020-12-28 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2020-12-27 |
| Ear, Nose, And Throat Image Analyzer | SHL | Class 2 | Ear, Nose, Throat | No | 2026-05-04 |
Proprietary Names
Tyto Insights for Wheeze Detection
Tyto Insights for Rhonchi Detection
Tyto Insights for Crackles Detection
TytoCare Pulse Oximeter
Tongue depressor
Tyto Insights for Eardrum Bulging Detection
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device