FDA Registration
Active
🇮🇱 Israel
SaliPen
Reg #: 3015282800
·
FEI: 3015282800
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SALIWELL LTD.
- Registration Number
- 3015282800
- FEI Number
- 3015282800
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3A Hatamar St.
- City
- Harutzim Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K180838
Owner / Operator
- Firm Name
- Saliwell Ltd.
- Operator Number
- 10059893
- Address
- 3A Hatamar St.
- City
- Harutzim
- State
- Central
- Postal Code
- 6091700
- Country
- IL
- Correspondent
- Andy Wolff
US Agent
- Business Name
- FDAIMPORTS LLC
- Contact Name
- FDAIMPORTS.COM LLC
- Address
- 2631 Housley Road, #1211
- City
- Annapolis
- State
- MD
- ZIP
- 21401
- Country
- US
- [email protected]
- Phone
- 410 2202800
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Salivary System | LTF | Class 2 | Dental | No | 2019-03-05 |
Proprietary Names
SaliPen
Establishment Types
Manufacture Medical Device