Medical Device Number

Medical Device Databases | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases

Apr 6, 2022

AccessGUDID - Identify Your Medical Device

https://accessgudid.nlm.nih.gov/

The Global Unique Device Identification Database (GUDID)contains key device identification information submitted to the FDA about medical devices that …

Establishment Registration & Device Listing - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/TextSearch.cfm

Importing Medical Devices | FDA

https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices

Registration and listing. Establishments that are involved in the production and distribution of …

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

Approvals and clearances, information on medical devices by type Digital Health Center of Excellence Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in …

GMDN Agency

https://www.gmdnagency.org/

The GMDN provides terms which name and group all medical device products and can be used to exchange medical device information and support patient …

How to Determine if Your Product is a Medical Device | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device

Step 1: Determine if your product meets the definition of a medical device per Section 201 (h) of the Food, Drug & Cosmetic Act. Step 2: Determine if an appropriate …

How to find the Medical Device Listing Number (MDL Number) …

https://elsmar.com/elsmarqualityforum/threads/how-to-find-the-medical-device-listing-number-mdl-number-from-the-fda-website.45979/

I believe you'd have to contact the manufacturer, per FDA "...medical device listing number (s) are not available publicly. Medical device listing numbers can only …

Classify Your Medical Device | FDA

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

Each classified device has a 7-digit number associated with it, e.g., 21 CFR 880.2920 - Clinical Mercury Thermometer. Once you find your device in the panel's beginning list, go …

Establishment Registration & Device Listing - Food and …

https://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfRL/rl.cfm?xss=1

FDA Home Medical Devices Databases This database includes: medical device manufacturers registered with FDA and medical devices listed with FDA Note: …