Compliance — Certifications, IP & Positioning

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 (KTR)

EMC 2014/30/EU

Korea Certification (EMC)

VCCI

Japan EMC

PSE

Japan Elec. Safety

ISO 9001

Quality Management

ISO 13485

Manufacturing QMS

In Progress

ISO 27001

Information Security

The Full Record

Every certification, on the table.

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

Item	Scope	Reference	Status
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 ApplicationAIQRM / SLM method	Pending application	10-2023-0168743	Pending
HS Code Ruling	Customs classification	품목분류1과-4068 · HS 9027.80	Classified
ISO/IEC 27001:2022	Information security management	SoA — 93 controls prepared	In Progress

Scope note · GS Grade 1 The GS Grade 1 certification covers software version v2.6. BIA-based body-composition features included in the latest generation fall outside the scope of that certified version and are described separately as wellness reference features.

Scope note · ISO 13485 ISO 13485 certifies CARNA AI's manufacturing quality-management system. It does not classify the HealthViewer as a medical device; the product remains a non-medical wellness reference tool.

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 · Software**No. 26-0063 · Software v2.6

KC conformity registration certificate — **KC Conformity Registration**Model CRAI-KIOCA-26

KC EMC test report — **KC EMC Test Report**Model CRAI-KIOCA-20

VCCI registration of product conformity — **VCCI Registration**Acc. 2026087226 · Japan

VCCI EMC test report — **VCCI EMC Test Report**Model CRAI-KIOCA-26

PSE test report — **PSE Test Report**IEC 62368-1

CE Declaration of Conformity — Health Viewer — **CE DoC · Health Viewer**CRAI-KIOCA-26 · UCSCE-2601-0004

CE Declaration of Conformity — Computer — **CE DoC · Computer**CRAI-KIOCA-26-P · UCSCE-2601-0006

CE Declaration of Conformity — Monitor — **CE DoC · Monitor**CRAI-KIOCA-26-M · UCSCE-2601-0005

**UAE Free Sale Certificate**CARNA-FSC-2026-UAE-001

Customs HS code classification ruling — **HS Code Ruling**HS 9027.80 · Customs

Certificate of Patent — KR 10-2776549 — **Patent Certificate**KR 10-2776549 · KIPO

Intellectual Property

The fusion method is protected.

The AIQRM multimodal-fusion method is protected by Korean Patent 10-2776549, registered 27 February 2025, with a further application under 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).
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 27001 in progress

A full ISMS Statement of Applicability (93 controls) is prepared; ISO/IEC 27001:2022 certification is in progress.

Certified.
Patent-protected.
Wellness-first.