FDA Registration
Active
🇸🇪 Sweden
ABIGO MEDICAL AB
Reg #: 8043991
·
FEI: 3004017406
·
Expires 2026
Products
1
Proprietary Names
9
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ABIGO MEDICAL AB
- Registration Number
- 8043991
- FEI Number
- 3004017406
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- MOLNDALS BRO 2
- City
- MOLNDAL Vastra Gotaland
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K143151
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 | 2023-11-24 |
Proprietary Names
Cutimed Siltec Sorbact B
Cutimed Sorbion Sorbact
Leukomed Sorbact
Cutimed Sorbact Dressing Pad
Cutimed Sorbact WCL
Cutimed Sorbact Swab
Sorbact
Cutimed Sorbact Ribbon
Cutimed Sorbact Gel
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198