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medical device listing codes and classifications

  1. H

    Classification of a Class IIb Medical Device with 3 Components

    My company will be a legal manufacturer a medical device. Overall it is classified as a IIb. However, there are three components to it. 1. A generator which delivers a specific type of power to the device 2. A grounding pad which is placed on to the patient (sterile), this is connected to...
  2. L

    Classification of Medical vs Wellness Devices

    Hello there, Thank you for all of the guidance you folks have provided on the forums so far. It has been very informative. I have been trying to get a handle on classification of digital health devices in Canada. I have not been able to locate a formal guidance document on the difference...
  3. S

    Mains outlet MSO definition

    We have a Class 2 device, on which we have a mains outlet. The outlet is intended for use with one specific device (our own class 2 PSU) which in turn is intended for use with one specific hand-held device. The mains outlet would be marked with a reference to the model/part number that can be...
  4. R

    Vertebroplasty - Medical Device Classification

    Hello everyone, Is a navigation medical device having a class 2a (EU classification) is authorized to be used in vertebroplasty or it should be classified 2B or 3 Thank you for your answers :)
  5. M

    Vacuum Blood Collection Tubes

    Are these tubes classified as Medical devices ? if yes what is the class. What are the regulatory standards in EU. Thanks michelle
  6. S

    Does the cable assembly supporting a medical device gets classified accordingly?

    I need advise on medical device classification - if there is a cable assembly that supports a Class 2 medical device, would the cable assembly be labeled as a Class 2 medical device too? This question is specifically from a device listing perspective for one of the cable supplier who just...
  7. chris1price

    Are these Active Medical Devices?

    Hi guys, I was recently asked my thoughts on a couple of devices; in particular, whether they should be classified as active devices. The two devices were a pressurised metered dose inhaler (using gas as a propellant) and an auto-injector pen using gas or spring power to create the...
  8. Gordon Mousedeer

    Uses of Medical Trays and Bowls

    Medical trays and bowls can become a reservoir of nosocomial infections. May I know what items are put into medical trays and bowls? I want to know if there are other reservoirs such as blood and pus that can cause cross-infection between patients from medical trays and bowls.
  9. N

    Applied Parts Classification Clarification - Breast Pump

    Hello, I am looking for some guidance with regards to applied parts classification. I have an electric breast pump device that very broadly consists of a mains adaptor, pump unit and breast pump horn (this is in contact with the patient and is connected to the pump via a tube). Am I...
  10. C

    Substance based Medical Device Classification under MDR - Rule 21

    Hello everybody! I’m studying the new MDR for medical device and I have a question related to classification. One of the new rule introduced in the MDR is the rule 21 which includes substance based medical devices. If I well understood all these medical devices will be classified under rule 21...
  11. supadrai

    Repacker/Relabeler (a/k/a/ Customer) is now shown as "Holder" of 510(k) in Database

    Hello all, We are a medical glove manufacturer. In reviewing our 510(k)s in the 510(k) database, one of our customers is now shown as being the Holder of one of our 510(k)s. There are no facts or documents to support them as owning any of our 510(k)s - they also appear as the Holder of many...
  12. supadrai

    Establishment registered as specification developer and foreign exporter only

    The factory shipped out some orders under prior paperwork using the device listing numbers from the establishment that's listed only as a spec developer and foreign exporter. There is no reference to the contract manufacturer. I believe this will get flagged by PREDICT because my...
  13. S

    Medical Device Classification - Laser Guided Positioner

    Dear Friends and Forum colleagues, I am kind of confused in classifying a product. Request your help. The Intended use of the product is something like this "This is an optical guidance system that intends to guide positioning and aligning of Needle for biopsy by traditional free-hand...
  14. shrutisancheti

    Exact Classification for Trans Radial Compression Device per EU directive 93/42/EEC

    Dear Friends, I wish to know the exact classification for Trans radial compression device as per EU directive 93/42/EEC. Kindly help. Thank you Best regards,
  15. W

    Determining Medical Device Classification in Mexico

    Hello, I'm trying to find out if a product my company sells in USA would be considered a medical device in Mexico. Not being fluent in Spanish has made this simple task a bit daunting. Is there information on the COFEPRIS web site? The product is a patient harness that would be used to prevent...
  16. renenatasha

    MDD Classification for Pressure Monitoring Set

    Good day, Clover :) I tried searching the thread but can't find anything that comes close to my doubt. In regards to classifying a pressure monitoring set (consists of a range of consumables and single use components), is it possible to classify the whole device lower (based on the...
  17. R

    Same Medical Device, Different Classifications By Different NB?

    Hi All! What say you when the same Medical Device gets classified as IIb by a NB and as IIa by a different NB? I have the certificates, one my own and competition downloaded from the world wide web. And to whom should this issue be reported? Thanks in advance!
  18. S

    Reclassification of a Medical Device by Health Canada

    Hi Everyone, What could be the possible ramifications if Health Canada chooses to reclassify your device from Class-I to Class-II? We already have an Quality Management system in place and are ISO 13485 certified. It would be great if someone has experience with reclassification of...
  19. D

    Down Classifying a Medical Device from Class II to Class I

    I have a question about what is perhaps a unique situation involving shifting classification of a device from Class II to Class I. My apologies, as this may be very difficult to explain without giving specifics; A company owns a device which was cleared via a 510(k) submission. It was...
  20. Q

    Medical Device Establishment Registration/Listing for Foreign Private Labeler

    Hello, I have a question relating to requirements for device establishment registration and listings for a foreign private labeler utilizing a foreign contract manufacturer. The private labeler is looking to distribute a Class II product in the US that has a current 510(k) through the...
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