FDA Registration
Active
🇮🇱 Israel
PREP SET CAT.#908
Reg #: 9611024
·
FEI: 3002807170
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Euroband Bioline LTD.
- Registration Number
- 9611024
- FEI Number
- 3002807170
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 31 GESHER HAETZ ST., INDUSTRIAL PARK EMEK HEFER
- City
- INDUSTRIAL PARK EMEK HEFER Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K802020
Owner / Operator
- Firm Name
- Euroband Bioline Ltd
- Operator Number
- 10047611
- Address
- GESHER HAETZ 31 ST., INDUSTRIAL PARK EMEK HEFER
- City
- INDUSTRIAL PARK EMEK HEFER
- State
- Central
- Postal Code
- 3877701
- Country
- IL
- Correspondent
- Noa Weber
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2014-12-08 |
Proprietary Names
PREP SET CAT.#908
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device