FDA Registration
Active
🇧🇪 Belgium
3D SYSTEMS - LAYERWISE
Reg #: 3010705004
·
FEI: 3010705004
·
Expires 2026
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- 3D SYSTEMS - LAYERWISE
- Registration Number
- 3010705004
- FEI Number
- 3010705004
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Grauwmeer 14
- City
- Heverlee Vlaams Brabant
- Country
- BE
Owner / Operator
- Firm Name
- LayerWise nv
- Operator Number
- 10048431
- Address
- 5381 South Alkire Circle
- City
- Littleton
- State
- CO
- Postal Code
- 80127
- Country
- US
- Correspondent
- Archana Gopalan
US Agent
- Business Name
- 3D Systems, Inc.
- Contact Name
- Archana Gopalan
- Address
- 5381 South Alkire Circle
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
- [email protected]
- Phone
- 720 6431001
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2024-08-16 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2023-11-10 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2023-11-10 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2017-03-24 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2025-07-24 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2015-01-13 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2022-10-28 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2023-01-25 |
Proprietary Names
Cervical Spacer
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)