Suresult Trust Center
Certifications & Compliance

Review our regulatory, quality, safety, and documentation records before purchase. Suresult provides documentation for buyers who need confidence in regulated medical device markets.

13 compliance records availableDocument library updated: May 21, 2026

  • FDA logo
    FDA 510(k)
    Wireless probe ultrasound scanner documentation available for buyer review.
  • Health Canada logo
    Canada / Health Canada
    Medical device license documentation available for buyer review.
  • CE marking
    EU MDR / CE
    European conformity and MDR-related quality documentation.
  • ISO logo
    ISO 13485 QMS
    Quality management system documentation for medical devices.
  • Global Documentation
    Regional registrations, safety evidence, and supporting summaries.
  • Therapeutic Goods Administration logo
    Australia / TGA
    ARTG medical device registration documentation for buyer review.
Certificate library

Documentation Available for Buyer Review

Search by certificate name, market, standard number, or issuing body. Open each document in a new tab for review.

Documents open after a free sign-in — create an account or log in once and every record unlocks.

13shown

Logos are displayed for document identification and buyer review. Certificate links open the underlying PDF records.

Regulatory Registrations
AustraliaPDF

Australia TGA ARTG Medical Device Registration

ARTG medical device registration documentation for the Australian market.

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United StatesPDF

FDA 510(k) K211985 Wireless Probe Ultrasound Scanner

FDA 510(k) documentation for the wireless probe ultrasound scanner.

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Brazil / ANVISAPDF

Brazil ANVISA Authorization Reference

Brazilian health surveillance authorization reference included in the global medical device documentation summary.

View Documentation
CanadáPDF

Health Canada Medical Device License 107656

Medical device license documentation for the Canadian market.

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EU / CE & MDR
EU / MDRPDF

EU MDR QMS Certificate Intertek NB2862

EU MDR-related QMS certificate issued by Intertek NB2862.

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EU / CEPDF

Suresult EU Declaration of Conformity (DoC) Wireless Probe Ultrasound Scanner

EU Declaration of Conformity (DoC) for Suresult wireless probe ultrasound scanner models, provided for CE / EU compliance document review.

View Declaration of Conformity
EU / CEPDF

EC Certificate Display Only 2028

EC certificate document available for display and buyer reference.

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Quality & Safety
Quality SystemPDF

ISO 13485 Certificate Medical Device QMS

Quality management system certificate for medical device operations.

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BiocompatibilityPDF

ISO 10993-1 Biocompatibility Assessment Summary

Biocompatibility assessment summary aligned with ISO 10993-1 considerations.

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Safety EvidencePDF

IEC 60601-1 Safety Evidence Review MDR Technical Documentation

Safety evidence review and MDR technical documentation summary.

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Safety DocsPDF

MDSAP SDS MSDS Documentation Summary

Supporting safety documentation summary, including SDS / MSDS-related records.

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Global / IP Documentation
GlobalPDF

Global Medical Device Authorizations Summary

Summary of global medical device authorization documentation for buyer review.

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IP / EUIPOPDF

EUIPO Intellectual Property Registration Summary

Intellectual property registration summary for brand and documentation review.

View Certificate
Document library

Built for Regulated Medical Device Markets

This document library is provided to help buyers review relevant regulatory, quality, safety, and supporting documentation before purchase. Availability of documentation does not replace destination-specific regulatory review where required.

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