FDA Registration
Active
🇸🇪 Sweden
DigniCap
Reg #: 3008888703
·
FEI: 3008888703
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DIGNITANA AB
- Registration Number
- 3008888703
- FEI Number
- 3008888703
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Traktorgranden 3
- City
- Lund Skane
- Country
- SE
Regulatory Submissions
- 510(k) Number
- DEN150010
Owner / Operator
- Firm Name
- Dignitana Inc
- Operator Number
- 10050834
- Address
- 10925 Estate LN, Suite W-185
- City
- Dallas
- State
- TX
- Postal Code
- 75238
- Country
- US
- Correspondent
- Niklas Lindgren
US Agent
- Business Name
- Dignitana, Inc.
- Contact Name
- Niklas Lindgren
- Address
- 10925 Estate Lane, Suite W-185
- City
- Dallas
- State
- TX
- ZIP
- 75238
- Country
- US
- [email protected]
- Phone
- 469 9175555
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Scalp Cooling System | PMC | Class 2 | General, Plastic Surgery | No | 2016-01-11 |
Proprietary Names
DigniCap
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility