FDA Registration
Active
🇮🇱 Israel
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD.
Reg #: 3013167159
·
FEI: 3013167159
·
Expires 2026
Products
5
Proprietary Names
4
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD.
- Registration Number
- 3013167159
- FEI Number
- 3013167159
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Derech Haifa 37, Kiryat Ata, P.O Box 25414
- City
- Kiryat Ata Haifa
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K191443
Owner / Operator
- Firm Name
- Medical Systems and Devices International Ltd.
- Operator Number
- 10059177
- Address
- Derech Haifa 37, P.O. Box 25414
- City
- Kiryat Ata
- State
- Northern
- Postal Code
- 2822639
- Country
- IL
- Correspondent
- Omri Elgerabli
US Agent
- Business Name
- Pragmatic Compliance Inc (Corporation)
- Contact Name
- Jerry Doane
- Address
- 15815 SW 11th Court Rd., 34473-8916
- City
- Ocala
- State
- FL
- ZIP
- 34473
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2021-01-14 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2018-12-09 |
| Attachment, Precision, All | EGG | Class 1 | Dental | No | 2021-01-14 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2021-01-14 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2021-01-14 |
Proprietary Names
Dental Accessories
MSDI Dental Tools
Attachments, precision attachment
Alef, Kaf, Taf MSDI Dental Implants System
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198