FDA Registration
Active
🇧🇪 Belgium
AMNOVIS BV
Reg #: 3022295665
·
FEI: 3022295665
·
Expires 2026
Products
7
Proprietary Names
5
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- AMNOVIS BV
- Registration Number
- 3022295665
- FEI Number
- 3022295665
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Betekomsesteenweg 47C
- City
- Aarschot Flanders
- Country
- BE
Owner / Operator
- Firm Name
- Amnovis BV
- Operator Number
- 10087492
- Address
- Betekomsesteenweg 47C
- City
- Aarschot
- State
- Flanders
- Postal Code
- 3200
- Country
- BE
- Correspondent
- Mindy McCann
US Agent
- Business Name
- Qserve Group US Inc.
- Contact Name
- Mindy McCann
- Address
- 350 S Main Street, Suite 309
- City
- Doylestown
- State
- PA
- ZIP
- 18901
- Country
- US
- [email protected]
- Phone
- 424 2718169
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2024-06-03 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2024-06-03 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2024-06-03 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2023-10-10 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2024-12-09 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2024-12-09 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-03-18 |
Proprietary Names
E3D-A Interbody System
E3D-C Interbody System
DYNAMIS Implant System
DYNAMIS SI Screw System
E3D-A-Interbody System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)