Materialise NV

Address:15 TECHNOLOGIELAAN,LEUVEN Vlaams Brabant,BE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Knee Arthroplasty Implantation System (OOG) (3) Medical Device Data System (OUG) (3) Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer (MBH) (3) Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive (OIY) (3) Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (JWH) (3) System, Image Processing, Radiological (LLZ) (2) Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (KWS) (2) Orthopaedic Surgical Planning And Instrument Guides (PBF) (1) Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer (HSX) (1) Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer (MBV) (1)

Premarket Exempt

No Yes

Clear

Lima PSI - E314SHCLM1000010 Catalog Number : SHC-LM10-00-01

Device Description : Lima CT Full scapula bone model

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Signature - E314SIGNATURE0 Catalog Number : Signature Planner

Device Description : Signature Planner

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : JWH, MBH, OOG, OIY, MBV

Prescription Use : No

Device Count : 1

Signature - E314SIGNATUREOMS0 Catalog Number : Signature online management system

Device Description : Signature online management system

Device Class : 1

Duns Number: 373139427

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

SurgiCase - E314SURGICASECMF0 Catalog Number : SurgiCase CMF

Device Description : SurgiCase CMF

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

SurgiCase - E314SURGICASECONNECT0 Catalog Number : SurgiCase Connect

Device Description : SurgiCase Connect

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : PBF

Prescription Use : No

Device Count : 1

SurgiCase - E314SURGICASECONNECTIP0 Catalog Number : SurgiCase Connect

Device Description : SurgiCase Connect (iPad)

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

SurgiCase Planner - E314SURGICASEKNEEPLAN0 Catalog Number : SurgiCase Knee Planner

Device Description : SurgiCase Knee Planner

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : OOG, OIY, MBH, JWH, HSX

Prescription Use : No

Device Count : 1

SurgiCase Online - E314SURGICASEONLINE0 Catalog Number : SurgiCase Online

Device Description : SurgiCase Online

Device Class : 1

Duns Number: 373139427

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

SurgiCase OOS - E314SURGICASEOOS0 Catalog Number : SurgiCase OOS

Device Description : SurgiCase OOS

Device Class : 1

Duns Number: 373139427

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

SurgiCase Planner - E314SURGICASEPLANNER0 Catalog Number : SurgiCase Planner

Device Description : SurgiCase Planner

Device Class : 2

Duns Number: 373139427

Premarket Exempt : No

Product Code : JWH, MBH, OIY, OOG, KWS

Prescription Use : No

Device Count : 1

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