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

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13 articles

19 February 2026

Aveir Leadless Pacemaker

CLS(MD) Level

Level 2 ✱

Manufacturer

Abbott Medical

Model: LSP112V Issued date: 19 February 2026 Expiry date: 19 February 2029

Implantable

CLS(MD) Product MDX00007

28 January 2026

myMerlinPulse Mobile Application

CLS(MD) Level

Level 1 ✱

Manufacturer

Abbott Medical

Model: APP1005 Issued date: 28 January 2026 Expiry date: 27 January 2029

Cardiovascular

CLS(MD) Product MDZ00005

28 January 2026

myMerlinPulse Mobile Application

CLS(MD) Level

Level 1 ✱

Manufacturer

Abbott Medical

Model: APP1004 Issued date: 28 January 2026 Expiry date: 27 January 2029

Cardiovascular

CLS(MD) Product MDZ00002

20 November 2025

Vercise Genus Implantable Pulse Generator System R32

CLS(MD) Level

Level 2 ✱

Manufacturer

Boston Scientific

Model: DB-1232 Vercise Genus™ R32 Implantable Pulse Generator Kit (M365DB12320) Issued date: 20 November 2025 Expiry date: 19 November 2028

Neurology

CLS(MD) Product MDX00013

20 November 2025

Vercise Genus Implantable Pulse Generator System R16

CLS(MD) Level

Level 2 ✱

Manufacturer

Boston Scientific

Model: DB-1216 Vercise Genus™ R16 Implantable Pulse Generator Kit (M365DB12160) Issued date: 20 November 2025 Expiry date: 19 November 2028

Neurology

CLS(MD) Product MDX00012

17 November 2025

Varian Ethos Treatment Planning

CLS(MD) Level

Level 1 ✱

Manufacturer

Varian Medical Systems Pacific, Inc.

Model: Ethos Treatment Planning 2.0 Issued date: 17 November 2025 Expiry date: 16 November 2028

Radiology

Image of the ethos machine

17 November 2025

Varian Ethos Treatment Management

CLS(MD) Level

Level 1 ✱

Manufacturer

Varian Medical Systems Pacific, Inc.

Model: Ethos Treatment Management 3.0 Issued date: 17 November 2025 Expiry date: 16 November 2028

Radiology

Image of the ethos machine

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