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Regulatory Status Statement

Last Update Date: 01-May-2026

1. Introduction

Shalink & Reyx Infinity Research Hub Pvt. Ltd. (“the Company”) is an India-based Artificial Intelligence research and innovation organization engaged in the development of advanced technologies in healthcare, public health systems, digital monitoring, and interdisciplinary scientific research.

This Regulatory Status Statement is intended to provide clarity regarding the Company’s current regulatory position, approvals, compliance status, and the developmental stage of its technologies, including AI-enabled wearable devices and research systems.

2. Nature of Organization

The Company operates as:

  • A private research and innovation entity
  • Engaged in Artificial Intelligence (AI) research and development
  • Focused on early-stage technology development, validation, and academic collaboration

The Company is not a government organization, statutory authority, or regulatory body.

3. Research and Development Status

All technologies, prototypes, and systems developed by the Company are currently:

  • In research, development, or pilot validation stages
  • Subject to ongoing testing, refinement, and academic evaluation
  • Intended for innovation, experimentation, and proof-of-concept validation

Unless explicitly stated, such technologies are not commercially deployed or clinically validated products.

4. Medical and Healthcare Technologies

Where the Company develops AI-based wearable devices or systems related to healthcare:

  • These technologies are under research and prototype stage
  • They are not certified medical devices unless explicitly approved by relevant authorities
  • They are not intended for clinical diagnosis, treatment, or medical decision-making

Use of such technologies must be limited to:

  • Research environments
  • Academic evaluation
  • Controlled pilot studies

Users and stakeholders must rely on qualified healthcare professionals for medical advice and decisions.

5. Regulatory Approvals and Certifications

As of the effective date of this statement:

  • The Company may not yet hold full regulatory approvals from authorities such as:
    • 1. Central Drugs Standard Control Organization (CDSCO)
    • 2. Indian Council of Medical Research (ICMR)
    • 3. Department of Scientific and Industrial Research (DSIR)
  • Any references to appreciation, collaboration, or communication with such bodies:
    • 1. Do not constitute formal approval, certification, or endorsement
    • 2. Are limited to academic interaction, guidance, or preliminary recognition

The Company is actively working towards meeting eligibility criteria for relevant certifications and recognitions.

6. DSIR and Government Recognition Status

The Company acknowledges the importance of recognition from bodies such as:

  • Department of Scientific and Industrial Research (DSIR)
  • Ministry of Science and Technology, Government of India

If the Company is

  • Registered / Recognized → It will be explicitly stated with official documentation
  • In Application Stage → The Company is in the process of applying and fulfilling requirements
  • Not Yet Applied → The Company is preparing for eligibility and compliance

No claim of DSIR recognition shall be made without formal approval.

7. Compliance with Indian Laws

The Company is committed to complying with applicable Indian laws and regulatory frameworks, including:

  • Information Technology Act, 2000
  • IT (SPDI) Rules, 2011
  • Digital Personal Data Protection Act, 2023
  • Applicable intellectual property laws
  • Research ethics and academic integrity guidelines

Where required, the Company will obtain approvals before commercial deployment of regulated technologies.

8. Ethical Research Commitment

The Company adheres to principles of:

  • Responsible AI development
  • Ethical data usage
  • Transparency in research
  • Protection of participant and user data

Human-related research, if conducted, shall follow:

  • Institutional ethical guidelines
  • Informed consent procedures
  • Applicable national and international standards
9. Collaborations and Institutional Engagement

Collaborations with:

  • Academic institutions
  • Research organizations
  • Government bodies

Are conducted for:

  • Research development
  • Knowledge exchange
  • Innovation validation

Such collaborations do not imply regulatory approval or endorsement, unless formally documented.

10. No Misrepresentation Clause

The Company strictly prohibits:

  • Misrepresentation of regulatory approvals
  • False claims of certification or government endorsement
  • Unauthorized use of names/logos of regulatory bodies

Any such representation shall only be made with valid, verifiable authorization.

11. Future Regulatory Intent

The Company intends to:

  • Apply for DSIR recognition for R&D status
  • Seek necessary approvals from CDSCO/ICMR for healthcare technologies
  • Align operations with national and international regulatory standards

All regulatory progress will be transparently updated on the official website.

12. Limitation of Interpretation

This statement:

  • Is for informational and transparency purposes only
  • Does not constitute legal certification or regulatory approval
  • Should not be interpreted as authorization for clinical or commercial use

Stakeholders are advised to verify regulatory status independently where required.

13. Contact for Clarification

For any queries regarding regulatory status, please contact:

Shalink & Reyx Infinity Research Hub Pvt. Ltd.

Email: info@shalinkai.com
Phone: +91 99523 03617
Website: www.shalinkai.com
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