Company
BelgiumPublic company, NASDAQ: MTLSMaterialise N.V. (NASDAQ: MTLS), Leuven, Belgium – FDA Inspections
Inspection records and compliance data for Materialise N.V. in Leuven. 3 FDA inspections on record, 1 Form 483, last inspected March 13, 2025. Publicly traded as NASDAQ: MTLS.
Company Profile
This profile covers Materialise N.V. based in Leuven, Belgium.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 6, 2014. Last inspected March 13, 2025.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Lack of or inadequate process validation1 inspection
- Records of complaint investigation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 13, 2025 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1264936 |
| February 2, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1003668 |
| February 6, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 868332 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Materialise N.V.
Stock ticker
MTLS
Exchange
NASDAQ
Share price
$6.59
Market cap
$389.3M
Price as of
November 13, 2026
FEI Number
3003998208
Address
Technologielaan 15, Leuven, Belgium
Country
Belgium
ID: 2a11f5c8-845b-4917-9ac6-c5dbfb216ec6