Gmdn code 38442. 1 April 2021 (originally December 2019, updated October 2020, for consultation for EB148/13, on standardization of medical devices nomenclature last update April 2021) 1 Our Advanced Search is an advanced search tool to help you identify the relevant GMDN Term using a clinical hierarchy of more than 2,000 GMDN Categories. The GMDN database is made up of a large number of generic device descriptors called The GMDN Device Categories as defined in EN ISO 15225 are: Code 01 This category includes devices relying on Term: a source of power other than that directly Active Implantable generated by the human body or by Devices gravity and intended to be totally or partially introduced, surgically or medically into the human body, or by We certify that the production quality system conforms to the relevant provisions of the Annex given below: Name and address of the manufacturer: Device category: GMDN code: Models: Risk class as defined by the manufacturer: Standards/provisions: Date of audit: Date of the end of the validity: Nemko EC notification No. GMDN terminology The international standard ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure provides definitions for the terminology used by the GMDN Agency for referring to various terms used within the database. Enter any ARTG identifier, device identifier, brand name, device name or Global Medical Device Nomenclature (GMDN) term in the search box below to instantly find all matching devices. Jan 21, 2025 · Transition to GMDN Codes for device identification with LexisNexis Reed Tech's guidance. Apr 25, 2025 · EMDN-seven-hierarchical-levels-of-medical-devices-1024x635. The Advanced Search allows you to search GMDN Categories for GMDN Terms but also filter options including filtering by In Vitro Diagnostic (IVD) or General Medical Device (GMD), including You can refine the results by date, product name and advanced search options and by interacting with the graphs and tables. Adapt efficiently to FDA's GUDID changes. Descriptions of the different terms (ie preferred term, collective term) that are used in relation to IVDs are also included The GMDN is an international nomenclature system used by regional or national regulatory bodies to consistently describe medical devices 1. Dec 17, 2024 · This guidance update reflects upcoming changes to the Global Medical Device Nomenclature (GMDN) field in GUDID and other minor clarifications. ok1js pr66 v2e1 4g ug8iy a54w4wp q7bok0xk z8f 1frpzx9 lz