FDA Registration
Active
🇸🇪 Sweden
TransitPellets
Reg #: 3015871081
·
FEI: 3015871081
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MEDIFACTIA AB
- Registration Number
- 3015871081
- FEI Number
- 3015871081
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- C/O IOffice Business Center, Kungsgatan 60
- City
- Stockholm
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K181760
Owner / Operator
- Firm Name
- Medifactia AB
- Operator Number
- 10061314
- Address
- c/o IOffice Business Center, Kungsgatan 60
- City
- Stockholm
- State
- SE-AB
- Postal Code
- 11122
- Country
- SE
- Correspondent
- Diana Nystrom
US Agent
- Business Name
- Pro Pharma Group
- Contact Name
- Cherita James
- Address
- 1129 20th St Nw Ste 600
- City
- Washington
- State
- DC
- ZIP
- 20036
- Country
- US
- [email protected]
- Phone
- 202 8411075
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Gastrointestinal Motility (Electrical) | FFX | Class 2 | Gastroenterology, Urology | No | 2019-10-07 |
Proprietary Names
TransitPellets
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility