Home/Compliance
Certified & Patent-Protected

Certified.
Patent-protected.
Wellness-first.

CARNA AI HealthViewer is engineered and tested against internationally recognized quality, safety and electromagnetic-compatibility frameworks — and positioned, deliberately and consistently, as a non-medical wellness reference device.

Regulatory positioning CARNA AI HealthViewer is a non-medical wellness and pre-screening reference tool. It does not diagnose, treat, cure or prevent disease, and it is not a substitute for clinical laboratory testing or professional medical examination. All outputs are wellness reference indicators, estimates and trend indicators. This positioning is applied consistently across every market in which CARNA AI operates.
At a Glance

Engineered to international standard.

Quality, safety and EMC frameworks across the Korean, Japanese, European and UAE markets.

GS Grade 1
Software Quality (KR)
CE
EMC 2014/30/EU
KC
Korea Certification (EMC)
VCCI
Japan EMC
PSE
Japan Elec. Safety
ISO 9001
Quality Management
ISO 13485
Manufacturing QMS
ISO 27001
Information Security
IAF
Accredited certification
Patents
Registered (KIPO)
Venture
Certified Venture Enterprise (KR)
The Full Record

Every certification, on the table.

Certifications, declarations, intellectual property and customs classification — with reference numbers.

ItemScopeReferenceStatus
GS Grade 1KTR · Software v2.6 Korean software quality certification No. 26-0063 · 12 Jun 2026 Certified
KC (EMC)CRAI-KIOCA-20 / -26 Korea electromagnetic compatibility JNDL-24ER-0957 · UCSKE-2601-0051 Certified
VCCI (EMC)CRAI-KIOCA-26 Japan electromagnetic compatibility UCSVC-2603-0001 · Acc. 2026087226 Registered
PSEIEC 62368-1 Japan electrical product safety UCSCL-2605-010 Certified
CE (DoC)EMC Directive 2014/30/EU EU declaration of conformity UCSCE-2601-0004 / -0005 / -0006 Declared
ISO 9001 Quality management system — Certified
ISO 13485 QMS for manufacturing — Certified
UAE Free Sale Certificate Free sale in the United Arab Emirates CARNA-FSC-2026-UAE-001 Issued
Patent (KR)AIQRM technology Registered Korean patent 10-2776549 · 27 Feb 2025 Registered
Patent (KR)AIQRM / SLM method Registered Korean patent Application 10-2023-0168743 Registered
HS Code Ruling Customs classification 품목분류1과-4068 · HS 9027.80 Classified
ISO/IEC 27001:2022 Information security management ISMS incl. AI software Certified
Official Documents

See the paperwork, first-hand.

Representative certificates, registrations, declarations of conformity and test reports behind the record above. Full-resolution originals are shared with qualified partners under NDA.

GS Grade 1 software quality certificate
GS Grade 1 · SoftwareNo. 26-0063 · Software v2.6
KC conformity registration certificate
KC Conformity RegistrationModel CRAI-KIOCA-26
KC EMC test report
KC EMC Test ReportModel CRAI-KIOCA-20
VCCI registration of product conformity
VCCI RegistrationAcc. 2026087226 · Japan
VCCI EMC test report
VCCI EMC Test ReportModel CRAI-KIOCA-26
PSE test report
PSE Test ReportIEC 62368-1
CE Declaration of Conformity — Health Viewer
CE DoC · Health ViewerCRAI-KIOCA-26 · UCSCE-2601-0004
CE Declaration of Conformity — Computer
CE DoC · ComputerCRAI-KIOCA-26-P · UCSCE-2601-0006
CE Declaration of Conformity — Monitor
CE DoC · MonitorCRAI-KIOCA-26-M · UCSCE-2601-0005
UAE Free Sale Certificate
UAE Free Sale CertificateCARNA-FSC-2026-UAE-001
Customs HS code classification ruling
HS Code RulingHS 9027.80 · Customs
Certificate of Patent — KR 10-2776549
Patent CertificateKR 10-2776549 · KIPO
CARNA AI measurement detail
Intellectual Property

The fusion method is protected.

The AIQRM multimodal-fusion method is protected by Korean Patent 10-2776549, registered 27 February 2025, and a second registered patent (application 10-2023-0168743) covering the biosignal-fusion SLM approach. Combined with a proprietary training dataset and multimodal sensing, the architecture is deliberately hard to imitate.

  • Patented AIQRM fusion method (KR 10-2776549) and SLM approach — all patents registered.
  • Proprietary 200,000+-record dataset behind the CARNA AI SLM.
  • Classified for global trade under HS 9027.80.
Trust By Design

Security and privacy, not an afterthought.

Personal wellness data is sensitive. CARNA AI treats it that way — with encryption, access control and an information-security program under active certification.

Encryption

Protected at rest

Sensitive fields are encrypted with modern authenticated encryption; report links are cryptographically signed and time-bound.

Access

Least-privilege

Institutional access is role-based, monitored in real time, and scoped to each partner's own data.

Governance

ISO/IEC 27001:2022 certified

An ISMS covering the platform and AI software, certified to ISO/IEC 27001:2022 with a full Statement of Applicability (93 controls).

Due Diligence

Need documents for review?

Certificates, test reports and IP records are available to qualified partners under NDA.

Request Documents → See the technology
Ask CARNA AI