How is Medical Device Number (MDL) assigned to companies?

#1
When registering a medical device product with FDA, you must enter the 3-alpha product code and then a medical device listing number (MDL) is assigned. Does anyone know if the "D" number is unique to each company or the same for all companies who use the same 3-alpha product code?
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
J Average number of Nonconformances during internal quality audit for Medical Device Manufacturers Internal Auditing 3
M Medical Device News TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia Medical Device and FDA Regulations and Standards News 0
shimonv GTIN Number on the Packaging of a Serviced Medical Device EU Medical Device Regulations 0
S Number of MOPP for Type BF Applied Part (Medical Device Electronics) IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E Number of medical device clinical trials has reduced by 20% in Korea Other Medical Device Regulations World-Wide 1
pittmatj Countries that require Medical Device Model Number Registration Other Medical Device Regulations World-Wide 3
G LST (Device Listing Number) for Medical Device Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
K FDA Medical Device Registration and Listing Number and Information Other US Medical Device Regulations 4
D I need a medical device listing number for for Tubigrip, Molnlycke US Food and Drug Administration (FDA) 4
C How to find the Medical Device Listing Number (MDL Number) from the FDA website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
O Sampling Plans for a Medical Device - What to use for my Accept and Reject Number? AQL - Acceptable Quality Level 3
P Control of Serial Number Label in Medical Device CE Marking (Conformité Européene) / CB Scheme 7
B Tracking Number of Uses of a Medical Device that can be Sterilized by the User ISO 13485:2016 - Medical Device Quality Management Systems 3
L Serial Number labeling for Class IIa Medical device packaged in multi-pack EU Medical Device Regulations 2
C Device Identification Number (DIN) - Canadian License for Medical Devices Canada Medical Device Regulations 8
J Medical Device QC Testing - Number of Samples as Batch Size Increases ISO 13485:2016 - Medical Device Quality Management Systems 13
C Labeling of Medical Devices - Distributor replacing device serial number label 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
C VOCs as extractable in substance based medical device EU Medical Device Regulations 0
S Mexico medical device registration - for demo Other Medical Device Regulations World-Wide 1
S EU Medical Device Regulations EU Medical Device Regulations 6
K Sample size calculation for the medical device with multiple indications. e.g. suture US Food and Drug Administration (FDA) 3
Doninina Trend Reporting for medical device class IIb according to MDR EU Medical Device Regulations 4
C Medical Device Gamma Irradiation Validation per VDmax25 (ISO 11137) Qualification and Validation (including 21 CFR Part 11) 1
S Medical device other market Medical Device and FDA Regulations and Standards News 1
Stoic Warning letter examples for medical device companies related to the pharma guidance on data integrity? US Medical Device Regulations 2
A 510(k) and DeNovo on same medical device for different indications? US Medical Device Regulations 4
I ISO13485 Folder Structuring for Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 5
S Change in material vendor - Medical device ISO 13485:2016 - Medical Device Quality Management Systems 4
I Medical Device Accessory Responsibility Other Medical Device Related Standards 7
B FDA regulations medical device prescription fulfillment DME question US Medical Device Regulations 0
J Medical Device Manufacturing Manufacturing and Related Processes 3
M An introductory guide to medical device Clinical Evaluation & Clinical Evaluation Reports (CER) EU Medical Device Regulations 0
O Regarding design and development requirements for a medical device EU Medical Device Regulations 6
U Leakage test Standard for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E Tablet integrated into medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
Ed Panek Is this a medical device? US Medical Device Regulations 2
P Medical device testing lab/service standard Other Medical Device Related Standards 1
K Medical Device file and "Component" Manufacturers? Other Medical Device and Orthopedic Related Topics 6
A Class 2b medical device - best pathway to obtain CE mark? (2022, MDR 2017/745) CE Marking (Conformité Européene) / CB Scheme 2
C Statistics/sampling plan for medical device Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
A Non-medical device testing in the medical system IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S Training in D&D for engineers with no medical device experience Design and Development of Products and Processes 8
M Software as Medical Device import activities for Chile and Mexico Other Medical Device Regulations World-Wide 0
M Medical Device Indications for Use Health Canada Canada Medical Device Regulations 6
D Exclusion 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 5
M Lifetime of medical device EU Medical Device Regulations 16
M UDI IVD Medical Device Class III US Food and Drug Administration (FDA) 1
E How to risk assess tooling? For a medical device and is it needed??? Manufacturing and Related Processes 2
P Definition of "Standalone" medical device Other Medical Device Regulations World-Wide 5
B Spare parts of medical device need CE mark? EU Medical Device Regulations 0

Similar threads

Top Bottom