FDA Registration
Active
🇧🇪 Belgium
Mimics Medical
Reg #: 3003998208
·
FEI: 3003998208
·
Expires 2025
Products
1
Proprietary Names
11
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
- K183105
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 |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2019-05-28 |
Proprietary Names
Mimics Medical
HeartPrint
Mimics Automatic Algorithms Knee MRI
Mimics Plugin Segment Thin Bone
Mimics Automatic Algorithms Knee CT
Mimics Automatic Algorithms CMF CT
Mimics Automatic Algorithms Heart CT
Mimics Plugin Compare Masks
Mimics Plugin RT Plugin
Mimics Automatic Algorithms Torso Bones CT
Mimics Automatic Algorithms Ankle CT
Establishment Types
Manufacture Medical Device