FDA Registration
Active
🇸🇪 Sweden
TIGR Matrix Surgical Mesh
Reg #: 3010187263
·
FEI: 3010187263
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- NOVUS SCIENTIFIC AB
- Registration Number
- 3010187263
- FEI Number
- 3010187263
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Virdings Alle 2
- City
- Uppsala
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K163005
Owner / Operator
- Firm Name
- Novus Scientific AB
- Operator Number
- 10034484
- Address
- Virdings Alle 2
- City
- Uppsala
- State
- SE-C
- Postal Code
- 754 50
- Country
- SE
- Correspondent
- Malin Kylberg
US Agent
- Business Name
- Global medical Partners
- Contact Name
- William Barrett
- Address
- 190 Industrial Road, Suite 2
- City
- Wrentham
- State
- MA
- ZIP
- 02093
- Country
- US
- [email protected]
- Phone
- 888 3848490
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mesh, Surgical, Absorbable, Abdominal Hernia | OWT | Class 2 | General, Plastic Surgery | No | 2017-08-10 |
Proprietary Names
TIGR Matrix Surgical Mesh
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device