FDA Registration
Active
🇮🇱 Israel
DREAMED DIABETES LTD
Reg #: 3013922904
·
FEI: 3013922904
·
Expires 2026
Products
4
Proprietary Names
2
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- DREAMED DIABETES LTD
- Registration Number
- 3013922904
- FEI Number
- 3013922904
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 14 Kaplan St. The Endocrinology Center, Schneider Childrens Medical Center
- City
- Petah Tikva Tel Aviv
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K191370
Owner / Operator
- Firm Name
- Dreamed Diabetes Ltd
- Operator Number
- 10058055
- Address
- 14 Kaplan Street, The Endocrinology Center Schneider Children Medical Center
- City
- Petah Tikva
- State
- Tel Aviv
- Postal Code
- 4920235
- Country
- IL
- Correspondent
- Adi Berkovitch
US Agent
- Business Name
- Medicsense USA
- Contact Name
- George Hattub
- Address
- 291 Hillside Avenue
- City
- Somerset
- State
- MA
- ZIP
- 02726
- Country
- US
- [email protected]
- Phone
- 508 4796116
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals | QCC | Class 2 | Clinical Chemistry | No | 2019-11-19 |
| Continuous Glucose Monitor Retrospective Data Analysis Software | PHV | Class 1 | Clinical Chemistry | No | 2019-06-01 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2019-05-27 |
| Calculator, Drug Dose | NDC | Class 2 | Anesthesiology | No | 2021-12-11 |
Proprietary Names
Device
endo.digital platform
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198