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Materialise Mimics Enlight CMF

FDA UDI

Class II (US FDA UDI)

by Materialise NV

Identity

Trade Name
Materialise Mimics Enlight CMF FDA UDI
Generic Name
CAD/CAM software FDA UDI
Device Name
Mimics Enlight CMF Reconstruction Planner FDA UDI
Model / Reference
Reconstruction Planner FDA UDI
Description
Mimics Enlight CMF Reconstruction Planner FDA UDI

Identifiers

Catalog Number
Reconstruction Planner FDA UDI
Primary DI / UDI-DI
05404028000816 FDA UDI
510(k) Number
K223427 FDA UDI
FDA Product Code
LLZ FDA UDI
DZJ FDA UDI
GMDN Term
CAD/CAM software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
872.4120 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

Yes

FDA UDI

Category: CAD/CAM software

Materialise Mimics Enlight CMF by Materialise NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as CAD/CAM software.

Cleared under the same submission

K223427 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Materialise NV

Sources (1)

  • FDA UDI 6b22f498-a272-46f3-ad4b-bf292e873afb 35 fields · synced May 30, 2026