FDA Registration
Active
🇸🇪 Sweden
Cutimed Sorbact Gel
Reg #: 8043991
·
FEI: 3004017406
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ABIGO MEDICAL AB
- Registration Number
- 8043991
- FEI Number
- 3004017406
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- MOLNDALS BRO 2
- City
- MOLNDAL Vastra Gotaland
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K100591
Owner / Operator
- Firm Name
- ABIGO MEDICAL AB
- Operator Number
- 9004891
- Address
- Vapenvagen 1, --
- City
- Askersund
- State
- SE-NOTA
- Postal Code
- 696 33
- Country
- SE
- Correspondent
- Marie Skoglund
US Agent
- Business Name
- BSN Medical Inc
- Contact Name
- SEAN ANDERSON
- Address
- 5825 CARNEGIE BLVD
- City
- Charlotte
- State
- NC
- ZIP
- 28209
- Country
- US
- [email protected]
- Phone
- 959 5997401
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2012-09-19 |
Proprietary Names
Cutimed Sorbact Gel
Sorbact
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility