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  • FDA Registration

    Issuing authority : U.S. Food and Drug Administration

    Valid period : 2025/12/31 - 2026/12/31

    FDA Registration for the manufacture of first aid supplies, medical consumables, and assembled first aid kits.

  • CE (MDR)

    Issuing authority : EU Notified Body

    Valid period : 2025/6/18 - 2026/6/17

    Demonstrates compliance of applicable medical devices with EU MDR requirements.

  • MDEL

    Issuing authority : Health Canada

    Valid period : 2025/7/25 - 2027/7/25

    Authorizes applicable medical device importing and distribution activities in Canada.

  • MHRA

    Issuing authority : Medicines and Healthcare products Regulatory Agenc

    Valid period : 2022/4/25 - 2030/10/1

    Registration for applicable medical devices placed on the Great Britain market.

  • UKCA

    Issuing authority : UK Approved Body

    Valid period : 2022/4/15 - 2030/10/1

    Demonstrates conformity of applicable products with UK regulatory requirements.

  • ISO 13485

    Issuing authority : Accredited Certification Body

    Valid period : 2026/4/12 - 2029/4/11

    Certifies the quality management system for the manufacture of medical devices and first aid supplies.

  • ISO 9001

    Issuing authority : Accredited Certification Body

    Valid period : 2024/6/17 - 2027/6/16

    Certifies the company's quality management system for consistent production and quality control.

  • BSCI

    Issuing authority : amfori / amfori-approved Audit Firm

    Valid period : 2025/10/13 - 2026/10/13

    Demonstrates compliance with responsible labor, workplace safety, and social responsibility requirements.

  • FSC

    Issuing authority : FSC-Accredited Certification Body

    Valid period : 2024/1/24 - 2029/1/23

    Supports responsible sourcing and traceability of FSC-certified paper and packaging materials.