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AVAESTA Health

Regulatory Compliance — UK Class I Positioning

v2.6.1 · Build 20260613

🚨 Emergency Notice

AVAESTA is not for emergencies. If you have severe symptoms, chest pain, breathing difficulty, neurological weakness, blood in stool, or feel seriously unwell — please seek urgent medical help or call 999 immediately. Do not use this platform instead of emergency care.

UK Class I Medical Device Software — Regulatory Positioning

AVAESTA Health is designed and operated as a UK Class I self-certifiable software platform. It does not claim to diagnose, treat, prevent, detect, screen for, rule out, or triage disease. It does not provide autonomous clinical decisions or treatment recommendations. All outputs are informational, educational, and wellness-support in nature only.

"AVAESTA Health supports clinicians, aesthetic practitioners and users with structured image capture, wellness observations, aesthetic assessment, documentation, education and professional consultation support. AVAESTA does not provide diagnosis, treatment recommendations, emergency triage or replacement for professional medical judgement."

Regulatory ClassUK Class I (Self-Certified)
MHRA FrameworkSoftware as a Medical Device (SaMD) — Class I
Classification BasisInformational/non-diagnostic; no diagnostic claim
Intended UsersClinicians, aesthetic practitioners, wellness users
CE/UKCA StatusClass I self-certification (no notified body required)
Versionv2.6.1 · Build 20260613
Structured image capture and upload
Non-diagnostic visual observation and documentation
Aesthetic assessment and wellness observation
Practitioner note-taking and documentation support
Educational information about visual health
Longitudinal image comparison and tracking
Consent form capture and management
Clinician-ready report generation (non-diagnostic)
General wellness indicator summaries
Audit logging for clinical governance
Professional consultation support tools
Risk and compliance documentation management
Diagnose any disease, condition or pathology
Provide treatment recommendations
Perform emergency triage or risk stratification
Replace clinical examination or professional judgement
Screen for, detect, rule out or predict disease
Claim to be an AI doctor or clinical decision support system
Provide autonomous clinical decisions
Recommend specific medications or procedures
Detect cancer, melanoma, or serious pathology
Perform pathology detection
Issue urgent referral requirements
Make diagnoses based on AI outputs

This report is for informational, educational, documentation and wellness-support purposes only. It is not a diagnosis, medical device diagnosis, treatment recommendation, emergency triage tool, or substitute for review by a qualified healthcare professional. Any concerning symptom, lesion, pain, bleeding, rapid change, or persistent abnormality should be reviewed by an appropriate clinician.

AVAESTA Health · UK Class I Self-Certified Software · v2.6.1 · Build 20260613 · This platform is for informational, educational, documentation and wellness-support purposes only. It is not a diagnosis, medical device diagnosis, treatment recommendation, emergency triage tool, or substitute for review by a qualified healthcare professional. © 2026 AVAESTA Health Ltd. All rights reserved.