FDA Registration
Active
🇮🇱 Israel
Bioprotect Balloon Implant
Reg #: 3014285231
·
FEI: 3014285231
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIOPROTECT LTD.
- Registration Number
- 3014285231
- FEI Number
- 3014285231
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8 Tsor Street
- City
- Tzur Yigal Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K222972
Owner / Operator
- Firm Name
- Bioprotect Ltd.
- Operator Number
- 10088617
- Address
- 8 Tsor Street
- City
- Tzur Yigal
- State
- Central
- Postal Code
- 4486200
- Country
- IL
- Correspondent
- George J Hattub
US Agent
- Business Name
- Medicsense USA LLC
- Contact Name
- George Hattub
- Address
- 291 Hillside Ave
- City
- Somerset
- State
- MA
- ZIP
- 02726
- Country
- US
- [email protected]
- Phone
- 508 4796116
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hydrogel Spacer | OVB | Class 2 | Radiology | No | 2023-08-31 |
Proprietary Names
Bioprotect Balloon Implant
Establishment Types
Manufacture Medical Device