FDA Registration
Active
🇸🇪 Sweden
INTEGRUM AB
Reg #: 3011386779
·
FEI: 3011386779
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- INTEGRUM AB
- Registration Number
- 3011386779
- FEI Number
- 3011386779
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Gemenskapens gata 9
- City
- Molndal Vastra Gotaland
- Country
- SE
Regulatory Submissions
- PMA Number
- P190009
Owner / Operator
- Firm Name
- Integrum AB
- Operator Number
- 10050627
- Address
- Gemenskapens gata 9
- City
- Molndal
- State
- Vastra Gotaland
- Postal Code
- SE-431 53
- Country
- SE
- Correspondent
- Annika M Fahlen
US Agent
- Business Name
- Integrum Inc.
- Contact Name
- Jeff Zanni
- Address
- 100 Montgomery Street, Suite 1780
- City
- San Francisco
- State
- CA
- ZIP
- 94104
- Country
- US
- [email protected]
- Phone
- 800 8058073
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees | PJY | Class 3 | Unknown | No | 2022-01-24 |
Proprietary Names
Osseoanchored prostheses for the rehabilitation of transfemoral amputees
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility