FDA Registration
Active
🇸🇪 Sweden
SurgiCube
Reg #: 3012992602
·
FEI: 3012992602
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TOUL MEDITECH AB
- Registration Number
- 3012992602
- FEI Number
- 3012992602
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Tunbytorpsgatan 31
- City
- Vasteras Vastmanland
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K163455
Owner / Operator
- Firm Name
- Toul Meditech AB
- Operator Number
- 10052761
- Address
- Tunbytorpsgatan 31
- City
- Vasteras
- State
- Vastmanland
- Postal Code
- 72137
- Country
- SE
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Air Filter Portable Apparatus | ORC | Class 2 | General, Plastic Surgery | No | 2024-10-24 |
Proprietary Names
SurgiCube
Establishment Types
Manufacture Medical Device