FDA Registration
Active
🇧🇪 Belgium
Match Point System
Reg #: 3003998208
·
FEI: 3003998208
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MATERIALISE N.V.
- Registration Number
- 3003998208
- FEI Number
- 3003998208
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 15 TECHNOLOGIELAAN
- City
- LEUVEN Vlaams Brabant
- Country
- BE
Regulatory Submissions
- 510(k) Number
- K170893
Owner / Operator
- Firm Name
- MATERIALISE N.V.
- Operator Number
- 9029485
- Address
- Technologielaan 15, --
- City
- Leuven
- State
- BE-NOTA
- Postal Code
- 3001
- Country
- BE
US Agent
- Business Name
- Materialise USA
- Contact Name
- Jenny Jones
- Address
- 44650 Helm Court
- City
- Plymouth
- State
- MI
- ZIP
- 48170
- Country
- US
- [email protected]
- Phone
- 734 2597017
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2017-06-28 |
Proprietary Names
Match Point System
Materialise Shoulder Planner
SurgiCase Shoulder Planner
Materialise SurgiCase Planner
Materialise Glenoid Positioning System
Materialise Glenoid Positioning System guides
Match Point System guides
Lima Personalized Surgical Instruments
SurgiCase Planner
Establishment Types
Manufacture Medical Device