FDA Registration
Active
🇨🇭 Switzerland
INFINETAMED AG
Reg #: 3038549074
·
FEI: 3038549074
·
Expires 2026
Products
4
Proprietary Names
0
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- INFINETAMED AG
- Registration Number
- 3038549074
- FEI Number
- 3038549074
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Kagiswilerstrasse 17
- City
- Sarnen Obwalden
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K251220
Owner / Operator
- Firm Name
- InfinetaMed AG
- Operator Number
- 10093879
- Address
- Kagiswilerstrasse 17
- City
- Sarnen
- State
- Obwalden
- Postal Code
- 6060
- Country
- CH
- Correspondent
- Avital Barlev
US Agent
- Business Name
- Veranex Inc.
- Contact Name
- Doug Dockhorn
- Address
- 5420 Wade Park Blvd., Suite 204
- City
- Raleigh
- State
- NC
- ZIP
- 27607
- Country
- US
- [email protected]
- Phone
- 919 8276653
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2025-11-16 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2025-08-17 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2025-07-27 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2025-07-27 |
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device