FDA Registration
Active
🇧🇪 Belgium
3D-SIDE
Reg #: 3013561205
·
FEI: 3013561205
·
Expires 2026
Products
7
Proprietary Names
4
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- 3D-SIDE
- Registration Number
- 3013561205
- FEI Number
- 3013561205
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Rue Dumont, 5
- City
- Mont Saint Guibert Brabant Wallon
- Country
- BE
Regulatory Submissions
- 510(k) Number
- K243509
Owner / Operator
- Firm Name
- 3D-Side
- Operator Number
- 10054501
- Address
- Rue Andre Dumont 5
- City
- Mont Saint Guibert
- State
- Brabant Wallon
- Postal Code
- 1435
- Country
- BE
- Correspondent
- Khanh Tran Duy
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2025-06-25 |
| Shoulder Arthroplasty Implantation System | QHE | Class 2 | Orthopedic | No | 2025-06-25 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2025-06-25 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2023-01-03 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-01-03 |
| Orthopaedic Surgical Planning And Instrument Guides | PBF | Class 2 | Orthopedic | No | 2023-01-03 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2023-01-03 |
Proprietary Names
Archer PSI System
3D-Ankle PLAN
ARCHER 3D
3D-Cut
Establishment Types
Manufacture Medical Device