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Cybersecurity Labelling Scheme for Medical Devices - CLS(MD) Product List

9 articles

30 July 2025

Us2

CLS(MD) Level

Level 1 ✱

Manufacturer

Eko.ai

Model: v2 Issued date: 30 July 2025 Expiry date: 29 July 2028

Cardiovascular

Logo of u2 product

13 May 2025

BrainCapture

CLS(MD) Level

Level 1 ✱

Manufacturer

Wellesta Healthcare

Model: BC-1 Issued date: 13 May 2025 Expiry date: 12 May 2028

Neurology

CLS(MD) Product MDX00008

2 April 2025

HistoCore Pegasus

CLS(MD) Level

Level 1 ✱

Manufacturer

Leica Microsystems

Model: 14048858005 Issued date: 02 April 2025 Expiry date: 01 April 2028

Pathology

CLS(MD) Product MDX00006

2 April 2025

HistoCore Pegasus Plus

CLS(MD) Level

Level 1 ✱

Manufacturer

Leica Microsystems

Model: 14048858007 Issued date: 02 April 2025 Expiry date: 01 April 2028

Pathology

CLS(MD) Product MDX00007

16 October 2024

aiTriage

CLS(MD) Level

Level 1 ✱

Manufacturer

TIIM Healthcare

Model: V1 Issued date: 16 October 2024 Expiry date: 15 October 2027

Cardiovascular

CLS(MD) Product MDX00001

16 October 2024

Aveir Leadless Pacemaker

CLS(MD) Level

Level 1 ✱

Manufacturer

Abbott Medical

Model: LSP112V Issued date: 16 October 2024 Expiry date: 15 October 2027

Cardiovascular

CLS(MD) Product MDX00002

16 October 2024

VELYS TM Hip Navigation for Windows

CLS(MD) Level

Level 1 ✱

Manufacturer

Johnson & Johnson

Model: 451580051 Issued date: 16 October 2024 Expiry date: 15 October 2027

Orthopedic

CLS(MD) Product MDX00003

16 October 2024

Vercise Genus Implantable Pulse Generator System

CLS(MD) Level

Level 1 ✱

Manufacturer

Boston Scientific

Model DB-1232 Vercise Genus™ Issued date: 16 October 2024 Expiry date: 15 October 2027

Neurology

CLS(MD) Product MDX00005

16 October 2024

VerciseTM Genus Implantable Pulse Generator System

CLS(MD) Level

Level 1 ✱

Manufacturer

Boston Scientific

Model DB-1216 Vercise Genus™ Issued date: 16 October 2024 Expiry date: 15 October 2027

Neurology

CLS(MD) Product MDX00004