Review Suresult wireless ultrasound documentation for the D, L and C series. This library brings together regulatory records, the EU Declaration of Conformity, quality management certificates, and technical and market documentation summaries. Each entry identifies the document type, reference and product family; full PDFs are available after sign-in.
Review documents by market, standard or product family.
Full PDF documents are available after a free sign-in. Public summaries remain available below.
Document dates refer to the supplied records. The library update date records when the files on this page were replaced.
Public summary for ARTG entry 360011, including the Australian sponsor, device classification and intended purpose. The supplied record names the portable wireless ultrasound system in the D, L and C series.
FDA 510(k) correspondence concerning an ultrasonic pulsed Doppler imaging system. The supplied document identifies Class II and product codes IYN, IYO and ITX, and names the D, L and C series.
Brazil-market documentation reference listing ANVISA Registro 81535520003 and process 25351.022590/2020-24. This dedicated file covers the portable wireless ultrasound D, L and C series.
Medical Device Licence 107656 identifies a Class III device family. Its accompanying device list includes CPROBE types C, CL, CT and L; consult that list for the recorded device identifiers.
EU Quality Management System certificate referencing Regulation (EU) 2017/745, Annex IX Chapters I and III. The supplied certificate identifies Intertek NB 2862 and the portable wireless ultrasound D, L and C series.
Manufacturer declaration referencing Regulation (EU) 2017/745 for the D, L and C series. The document includes classification, the conformity-assessment route, and a list of applicable standards, including biological evaluation and electrical safety references.
ISO 13485:2016 quality management system certificate. The stated scope covers design, manufacture and servicing of diagnostic ultrasound systems and the portable wireless ultrasound D, L and C series.
Document-based technical review summary referencing IEC 60601-1 and EU MDR. It organizes electrical safety, essential performance, risk-management and software/usability evidence for the D, L and C series.
Summary of quality-system and material-safety documentation for the D, L and C series. It describes MDSAP framework mapping, ISO 13485 links, supplier records and SDS/MSDS file controls.
International market-documentation summary for the D, L and C series. It organizes country-level records, labeling and instructions for use, representative information and post-market documentation by market.
){kind=logo}
European intellectual-property documentation summary for the D, L and C series. It organizes brand and design records, technical dossiers, product-family references and portfolio maintenance information.
The supplied documents name the D, L and C series. Check the model and device-identifier list within the relevant PDF when matching a specific probe to a record.
The declaration states the manufacturer’s conformity position for the listed device family. A QMS certificate describes the assessed quality management system and its scope. Both document types are identified separately above.
The Brazil ANVISA entry now opens its own dedicated reference PDF, separate from the Global Medical Device Authorizations Summary.
Select the document button, then sign in or create a free account. After sign-in, the requested PDF opens for review.
Start with the relevant market record and its product scope. The EU Declaration of Conformity describes the manufacturer declaration; QMS certificates describe quality-system scope. Technical and market summaries organize supporting evidence and should be read alongside the underlying documents.
No account yet?
Create an Account
