FDA Registration
Active
🇸🇪 Sweden
MICROPOS MEDICAL AB
Reg #: 3026961165
·
FEI: 3026961165
·
Expires 2026
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
- 2026
- 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
- MedEnvoy Global Inc.
- Contact Name
- Daryl Wisdahl
- Address
- 10900 Research Blvd Ste 160c
- City
- Austin
- State
- TX
- ZIP
- 78759
- Country
- US
- [email protected]
- Phone
- 512 2560570
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 Transmitter tester
RayPilot Power box
RayPilot Software
RayPilot HypoCath
RayPilot System Cable
RayPilot Quality Control kit
RayPilot Receiver
RayPilot Extension plate
RayPilot ViewCath
RayPilot Matching Network
RayPilot Transmitter Cable
RayPilot Table displacement meter
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198