2008年3月27日 · Code : 45042 Term : Syringe, hypodermic, metered-delivery, retractable-needle Definition : A device comprised of a graduated barrel with plunger and an attached retractable-needle designed to deliver (infuse) an accurate metered dose of a substance (e.g., medicine or drug) during an injection.

2015年2月3日 · Medical Devices, Medical Information Technology, Medical Software and Health Informatics

2011年6月30日 · We have been asked for a UMDNS Code for 2 of our products and I've searched high and low and can't find codes specific to these products. One of the products is our Anti-Fog Guard which is an anti-fog solution formulated, without alcohol, to provide excellent levels of anti-fog protection from distortion of endoscope glass optics.

2014年11月2日 · Hello, I work for an IVD reagent company, who manufactures hundreds of clinical chemistry reagents. All of our reagents are self certified and conform to IVDD Annex III. Currently, each reagent has its own technical file, and it takes many months to review and update these files every two...

2025年2月5日 · This looks like an attractive option, but it is a subscription-based package, $175.00 USD/year. My company hates subscription-based software, would be a tough sell even at that low price.

2024年4月22日 · It is acceptable (in my experience) to have multiple EMDN codes on a single DoC, in much the same way that it is acceptable to have multiple devices within a single technical file (so long as the grouping of devices is logical, based on having the same product codes or similarity of design, intended purpose, etc.).

2007年7月24日 · Hi I have been asked for the GMDN codes for our products as part of product registration. Is there any way to access the codes without having to be a member of the GMDM, which costs €1500 + €1000 per year? For IVDs, I can find a cross reference between EDMA and GMDN which lists all IVD...

2009年7月3日 · Product Code is a primary code, while subsequent product code is a secondary code, for additional feature(s) that predicate devices of the primary code don't have. In that way the device is a combo device - it is a combination (or …

2010年12月31日 · In our ISO 13485 certificate (we manufacture components for medical devices), it states the following - EAC - 19 Simple Code - 014 NACE - 33.1 I tried to look into the NACE codes but found that 33.1 is for Repair of fabricated metal products, machinery and equipment Can somebody give...

2022年2月15日 · If something is explained in a different way (let's say IT code/function listed in the matrix but in the audit is explained that the mfg. site does not receive IT support from the Remote Location) that is enough argument to give us a nonconformity. Which is similar to why we received one (different code/function though).