FDA Registration
Active
🇸🇪 Sweden
RayPilot Table displacement meter
Reg #: 3026961165
·
FEI: 3026961165
·
Expires 2025
Products
1
Proprietary Names
12
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- MICROPOS MEDICAL AB
- Registration Number
- 3026961165
- FEI Number
- 3026961165
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Adolf Edelsvards gata 11
- City
- Goteborg Vastra Gotaland
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K203722
Owner / Operator
- Firm Name
- Micropos Medical AB
- Operator Number
- 10085838
- Address
- Adolf Edelsvards gata 11
- City
- Goteborg
- State
- Vastra Gotaland
- Postal Code
- 41451
- Country
- SE
- Correspondent
- Hanna Syren
US Agent
- Business Name
- Micropos Medical Inc
- Contact Name
- Thomas Lindstrom
- Address
- 263 Shuman Boulevard, Suite #145
- City
- Naperville
- State
- IL
- ZIP
- 60563
- Country
- US
- [email protected]
- Phone
- 331 3000009
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2023-03-20 |
Proprietary Names
RayPilot Table displacement meter
RayPilot ViewCath
RayPilot Transmitter Cable
RayPilot Software
RayPilot Transmitter tester
RayPilot Quality Control kit
RayPilot HypoCath
RayPilot Matching Network
RayPilot Extension plate
RayPilot Receiver
RayPilot Power box
RayPilot System Cable
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device