Trevor Mayhew Thanks Joanne,

They are used purely during the sterilisation and cleaning process without a specific medical purpose. The supplier has told me today that they are classed as medical devices but not which class. I've asked for a D of C from them.

Thank you for your comments. I still think they shouldn't be medical devices but the supplier says it's because they for an integral part of a cleaning system.

They may be considered under MDD as an accessory to a medical device (namely the sterilizer), which may cause them to be classified. May want to ask your registrar to be sure. That might be what the supplier is referring to.

Abdul Haleem Dear Trevor M,
Sterilisation Trays falls in medical devices category and belongs to class I and treated with the same protocol as class I instruments.

Haliem A. Malik

Yarsons International

Trevor Mayhew Thanks to everybody for your comments. The products themselves are actually CE marked but I was curious as to the justification for this. I'm going to leave them as they are!

Thanks again.

Trevor Mayhew I'll do that. Thanks Joanne.

Class II per FDA - See similarly approved 510K: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=2437
Good Luck.

Auke Poutsma Dear Trevor,
Yes these trays are Class I according to the MDD. As such the DoC as mentioned before should be clear on this. These trays are critical for desinfection and sterilization processes. In Europe some local country requirements apply as well to make it a bit more complex.

Auke Poutsma Dear Trevor,
Yes these trays are Class I according to the MDD as said by Abdul. As such the DoC as mentioned before should be clear on this. These trays are critical in the CSA relative to desinfection and sterilization processes. In Europe some local country requirements apply as well to make it a bit more complex.

Auke Poutsma Dear Trevor,
Yes these trays are Class I according to the MDD as said by Abdul. As such the DoC as mentioned before should be clear on this. These trays are critical in the CSA relative to desinfection and sterilization processes. In Europe some local country requirements apply as well to make it a bit more complex.

Trevor Mayhew Thanks to everybody for your comments. I'm a lot clearer now on the classification of these devices. Hope I can help others in the future!

Robert Barber They used to be Class 1 under FDA's classification, but were upgraded to Class 2 some years ago when FDA changed the classification rules, so its a good idea to check your 510(k) was updated to Class 2 if its an older product. They've always been Class I under MDD. Also, if they are designed for EtO reprocessing, FDA will expect to see EtO residuals test data in your 510(k).

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