FDA Registration
Active
🇸🇪 Sweden
VagiVital Aktivgel
Reg #: 3019793660
·
FEI: 3019793660
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Peptonic Medical AB
- Registration Number
- 3019793660
- FEI Number
- 3019793660
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Gustavslundsvagen 143
- City
- Bromma Stockholm
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K200098
Owner / Operator
- Firm Name
- Peptonic Medical AB
- Operator Number
- 10082253
- Address
- 4472 Saint Andrews Blvd
- City
- Irving
- State
- TX
- Postal Code
- 75038
- Country
- US
- Correspondent
- Mikael A Svensson
US Agent
- Business Name
- PEPTONIC MEDICAL AB
- Contact Name
- Mikael Svensson
- Address
- 4472 Saint Andrews Blvd
- City
- Irving
- State
- TX
- ZIP
- 75038
- Country
- US
- [email protected]
- Phone
- 310 4987448
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lubricant, Personal | NUC | Class 2 | Obstetrics/Gynecology | No | 2021-07-01 |
Proprietary Names
VagiVital Aktivgel
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device