FDA Registration
Active
🇸🇪 Sweden
OneTwo Prio
Reg #: 3028170577
·
FEI: 3028170577
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ONETWO ANALYTICS AB
- Registration Number
- 3028170577
- FEI Number
- 3028170577
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Kungsgatan 84
- City
- Stockholm
- Country
- SE
Owner / Operator
- Firm Name
- OneTwo Analytics AB
- Operator Number
- 10088626
- Address
- Kungsgatan 84
- City
- Stockholm
- State
- SE-AB
- Postal Code
- S-112 27
- Country
- SE
US Agent
- Business Name
- STeeP originals, LLC,
- Contact Name
- Steven Pusterla
- Address
- 8545 Seacrest Dr
- City
- Vero Beach
- State
- FL
- ZIP
- 32963
- Country
- US
- [email protected]
- Phone
- 973 4764776
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Glucose Monitor Retrospective Data Analysis Software | PHV | Class 1 | Clinical Chemistry | No | 2023-09-07 |
Proprietary Names
OneTwo Prio
OneTwo Insights
OneTwo Diabetes
Establishment Types
Manufacture Medical Device