The German Medical Devices Act (Medizinproduktegesetz, MPG) required a consistent, structured naming for the notification of in-vitro diagnostic devices. For this purpose, the EDMAIVD Classification, the product classification of the European Diagnostic Manufacturers Association (EDMA), had to be used.

2020年12月16日 · MedTech Europe has created a specific classification scheme for IVDs, the Global IVD (GIVD) classification (previously known as EDMA classification). It is a numerical coding system, which has been developed for the purpose to support the collection and analysis of market statistics.

2009年3月24日 · EDMA, the European Diagnostic Manufacturers Association is the trade association that represents the In Vitro Diagnostic (IVD) industry active in Europe. In Vitro Diagnostics are the...

Market statistics for IVD products have been established in 15 European countries using the “EDMA Classification” for unambiguous definition of the individual product segments. In 1988 the classification included around 340 individual Diagnostic …

EDMA IVD PRODUCT CLASSIFICATION INSTRUMENTS EDMA CODE Company Instrument-Name Page 22 IMMUNOCHEMISTRY INSTRUMENTS 14 22 01 RIA Equipment 22 01 01 RIA Counter 22 02 Protein Analyser 22 02 01 Small Protein Analyser 22 02 02 Large Protein Analyser 22 03 Immunoassay Analyser 22 03 01 Manual I.A. Instruments / Readers 22 03 02 Semi-automated I.A. Systems 15 22 03 03 Automated I.A. Systems 16

EDMA, the European Diagnostic Manufacturers Association, represents national associations and major companies engaged in the research, development, manufacturing or distribution of in vitro diagnostic (IVD) tests in Europe. The mission of EDMA is to raise awareness of the importance, usefulness and added value that diagnostic information can ...

EDMA, the European Diagnostic Manufacturers Association is the trade association that represents the In Vitro Diagnostic (IVD) industry active in Europe. In Vitro...

2024年11月21日 · 为推动新版《体外诊断试剂分类目录》发布后的顺利实施，依据《体外诊断试剂分类规则》和新版《体外诊断试剂分类目录》，基于现阶段科学认知和共识，根据申请人提供的资料，我中心对既往公开的体外诊断试剂产品进行了梳理和汇总。 汇总公布的分类界定结果不代表对其产品安全性和有效性的认可，仅作为医疗器械产品注册或备案的参考。 结果中产品描述和预期用途是用于判定产品的管理属性和类别，不代表相关产品注册或备案内容的完整表述。 本次汇 …

2011年10月18日 · The European Diagnostic Manufacturers Association (EDMA) was founded to represent national associations of the in vitro diagnostics (IVD) industry at European level in 1979.

European Diagnostic Manufacturers Association EDMA Classification & Groupings Version 7 - EDMA Classification Overview level 1 & 2 November 2007. Published by Stanley Tate Modified over 9 years ago Embed