Regulatory labelling under the UK Medical Devices Regulations 2002 (as amended).
| Device name | Aryash Patient Health Explainer |
|---|---|
| Version | 2.0 (4-module scope) |
| Date of first manufacture | 19 April 2026 |
| Current version released | 21 April 2026 (v2.0 scope revision: 4 active modules) |
| Conformity |
UKCA
Class I self-certification · no Approved Body required
MHRA registration pending (submission in progress).
|
| MHRA registration number | Pending registration |
| GMDN code | 64275 · Patient general health self-management software |
| Legal name | Aryash Health Limited |
|---|---|
| Company number | 17001109 (Companies House, England & Wales) |
| Registered address | C/O Charles Rippin & Turner, 130 College Road, Harrow, England, HA1 1BQ |
| Clinical lead | Dr Krishnan Pasupathi MBBS MBA MRCGP (GMC: 6050795) |
| Contact | feedback@aryash.health |
| Name | Aryash Health Limited |
|---|---|
| Address | C/O Charles Rippin & Turner, 130 College Road, Harrow, England, HA1 1BQ |
Aryash Health Limited is the manufacturer and is UK-established, so the same entity fulfils the UK Responsible Person duty under UK MDR 2002.
| Regulation | UK Medical Devices Regulations 2002 (SI 2002/618, as amended) |
|---|---|
| Classification | Class I (general medical device) |
| Rule | Rule 12 (Annexe IX) — all other active devices not covered by Rules 9, 10, or 14 |
| Conformity route | Annexe VII — UK Declaration of Conformity (self-declaration) |
| IVD status | Not an in-vitro diagnostic device — does not analyse biological samples |
| NICE ESF tier | Tier C — Inform / drive clinical management |
The Aryash Patient Health Explainer is patient general health self-management software (GMDN 64275) that provides plain-English explanations of health information encountered by UK adults — including investigations and test results, prescribed medicines, common health conditions, and cardiovascular risk factors. It is delivered as a modular platform under a single intended purpose: each module covers a distinct area of health information and is released as a version update of the same device.
Where a module accepts patient-entered clinical data (currently Module 1), the device compares that data against UK reference information and provides plain-language content and worked patient examples where clinically relevant. Other modules are read-only and present UK-anchored reference information. The device does not analyse samples, does not diagnose conditions, does not compute cardiovascular or other risk scores, does not recommend treatment, and does not replace clinical judgement.
For full detail, see the Intended Use Statement (AHL-TOOLS-DOC-001) and the Instructions for Use (AHL-TOOLS-DOC-005).
| Module 1 — Blood Test Explainer (v1.0) | Active. 50 routine UK blood tests at tools.aryash.health, supported by audio guides and downloadable infographics. Accepts a single numeric blood test value and displays its position on a UK reference scale. Clinical evaluation complete. |
|---|---|
| Module 2 — Cardiovascular Risk Explainer | Active. Plain-English explanations of QRISK3 cardiovascular risk, cholesterol, and lifestyle-based risk reduction at heartcheck.aryash.health. Signposts to NHS-validated external calculators; does not compute a risk score. Clinical evaluation in progress. |
| Module 3 — Heart Health Explainer | Active. Plain-English explanations of common cardiac conditions, investigations, and medications at heart.aryash.health. Clinical evaluation in progress. |
| Module 4 — Men's Health Explainer | Active. Plain-English explanations of prostate, testicular, sexual, hormonal, and men's mental-health topics at mens.aryash.health. Clinical evaluation in progress. |
New modules are released as version updates of the Aryash Patient Health Explainer under the same intended purpose and MHRA registration.
qrisk.org.