FDA Registration
Active
🇨🇭 Switzerland
POSITRIGO AG
Reg #: 3032577207
·
FEI: 3032577207
·
Expires 2026
Products
1
Proprietary Names
4
Establishment Types
4
Classifications
1
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Registration Details
- Registration Name
- POSITRIGO AG
- Registration Number
- 3032577207
- FEI Number
- 3032577207
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Technoparkstrasse 1
- City
- Zurich
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K241751
Owner / Operator
- Firm Name
- Positrigo AG
- Operator Number
- 10091382
- Address
- Technoparkstrasse 1
- City
- Zurich
- State
- CH-ZH
- Postal Code
- 8005
- Country
- CH
- Correspondent
- Jannis Fischer
US Agent
- Business Name
- Positrigo Inc.
- Contact Name
- Brian Oswald
- Address
- C/O Wg Service Partners Llc, Wall Street Plaza; 88 Pine St Fl 20
- City
- New York
- State
- NY
- ZIP
- 10005
- Country
- US
- [email protected]
- Phone
- 305 9234283
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Tomography, Computed, Emission | KPS | Class 2 | Radiology | No | 2024-09-12 |
Proprietary Names
NeuroLF (Basic)
NeuroLF (Pro)
NeuroLF (Advanced)
NeuroLF Seat
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device