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HOME Certificates

Trusted by Healthcare Professionals Worldwide

Every product we manufacture is backed by internationally recognized certifications. Our quality management system has been independently audited and approved by the world's leading regulatory bodies.

CE CertifiedISO 13485FDA Registered
QUALITY ASSURANCE

A Commitment To Safety, Consistency, And Clinical Confidence.

At Double Medical Instruments Limited, quality is not a department — it's the foundation of everything we make. From raw material selection to final sterile packaging, every stage of production is governed by a strictly controlled quality management system aligned with ISO 13485:2016 and EU MDR 2017/745.

Our dedicated QA/QC team performs more than 40 checkpoints across the production lifecycle, ensuring every single unit that leaves our facility meets or exceeds international regulatory expectations.

  • 40+

    Quality control checkpoints

  • 100K

    Class cleanroom facility

  • 15+

    Regulatory certifications

  • 99.8%

    First-pass yield rate

Our Credentials

Officially Recognized. Globally Accepted.

Below are the core certifications that allow our disposable medical consumables to be distributed and used in hospitals, clinics, and distribution networks across more than 60 countries.

  • CE Certificate
    CE Certificate
    CE Certificate
    Issued by TÜV SÜD Product Service
    Our CE certification confirms that our disposable medical devices conform to the essential health, safety, and environmental requirements of the European Medical Device Regulation (MDR 2017/745). This enables full legal sale and distribution throughout the European Economic Area and beyond.
    • Certificate No.

      CE-MDR-2024-0891

    • Valid Until

      May 2029

    • Scope

      Class I, IIa devices

    Download certificate (PDF)
  • ISO 13485 Certificate
    ISO 13485 Certificate
    ISO 13485 Certificate
    Issued by BSI Group — Accredited Body
    ISO 13485:2016 is the internationally recognized standard for medical device quality management systems. Our certification demonstrates that every stage of our operation — from design and production to storage, distribution, and post-market surveillance — meets the rigorous standards expected by regulators and global healthcare partners.
    • Certificate No.

      MD-672451-2023

    • Valid Until

      September 2026

    • Scope

      Design & manufacture

    Download certificate (PDF)
  • FDA Registration
    FDA Registration
    FDA Registration
    U.S. FOOD & DRUG ADMINISTRATION
    Double Medical Instruments Limited is registered with the United States Food and Drug Administration as an authorized establishment, with listed device products under the appropriate regulatory categories. This registration supports compliant importation and distribution within the U.S. healthcare market. It reflects our dedication to meeting the stringent requirements of one of the world's most demanding regulatory bodies.
    • ESTABLISHMENT #

      3016284719

    • STATUS

      Active — Renewed Annually

    • LISTINGS

      510(k) Class I / II

    View FDA registration
Additional Approvals

Certified for Markets Around the World

Beyond core certifications, we comply with regional standards that allow broader distribution across Asia, the Middle East, Latin America, and Africa.

  • MDSAP

    Medical Device Single Audit Program

  • ISO 9001:2015

    General QMS Certification

  • ANVISA

    Brazilian Health Authority

  • NMPA

    China Drug & Device Authority

  • SFDA

    Saudi Food & Drug Authority

  • TGA

    Therapeutic Goods — Australia

  • PMDA

    Pharmaceutical Authority — Japan

  • REACH / RoHS

    Material Compliance (EU)

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