Identity
- Trade Name
- Mimics FDA UDI
- Generic Name
- CAD/CAM software FDA UDI
- Device Name
- Mimics Medical FDA UDI
- Model / Reference
- Mimics Medical FDA UDI
- Description
- Mimics Medical FDA UDI
Identifiers
- Catalog Number
- Mimics Medical FDA UDI
- Primary DI / UDI-DI
- E314MIMICSMEDICAL0 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- CAD/CAM software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: CAD/CAM software
Mimics by Materialise NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CAD/CAM software.
- CEREC — Sirona Dental Systems GmbH · Class II
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- CAD/CAM Software — Sirona Dental Systems GmbH · Class II
- CEREC Guide — Sirona Dental Systems GmbH · Class I
- CEREC Guide — Sirona Dental Systems GmbH · Class I
- CEREC Guide — Sirona Dental Systems GmbH · Class I
- CAD/CAM Software — Sirona Dental Systems GmbH · Class II
- CEREC Guide — Sirona Dental Systems GmbH · Class I
Cleared under the same submission
K073468 also covers:
K183105 also covers:
- HeartPrint — Materialise NV
- HeartPrint — Materialise NV
- Mimics — Materialise NV
- Mimics — Materialise NV
- Mimics — Materialise NV
- Mimics — Materialise NV
- Mimics — Materialise NV
- Mimics — Materialise NV
- Mimics — Materialise NV
- Mimics — Materialise NV
- Mimics — Materialise NV
- Mimics Automatic Algorithms — Materialise NV
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Materialise NV
Sources (1)
- FDA UDI de2965ef-8c0f-4b4a-be99-73acf8c9ff38 35 fields · synced Jun 1, 2026