General Medical Device Classification Program

Does this device incorporate human blood, blood products, plasma or blood cells of human origin, except for stable derivatives device?

Is this device a transplant or tissues or cells of human origin or product incorporating or derived from tissues or cells of human origin?

Is this device a transplant or tissues or cells of animal origin, unless it is manufactured utilizing animal tissue which is rendered non-viable or non-viable products derived from animal tissues?

Does this device incorporate viable animal or human cells / tissues / derivatives?

Does this device come in contact with intact skin ONLY?

Is this device intended for disinfecting, cleaning, rinsing or hydrating contact lenses?

Is this device intended for disinfecting medical devices prior to end point sterilization or higher level disinfection?

Is this device an implantable or long-term invasive device?

Is this device intended for continuous use for less than 60 minutes?

Is this device intended for continuous use for more than 30 days?

Is this device intended to control or monitor the performance of Class III active therapeutic devices or intended directly to influence the performance of such devices?

Can this device administer or exchange energy to or from the human body in a potentially hazardous way, including ionizing radiation, taking account of the nature, the density and site of application of the energy?

Is this device intended to emit ionizing radiation and intended for diagnostic and/or interventional radiology, including devices which control or monitor such devices, or those which directly influence their performance?

Is this device specifically intended for the functions described below?

a) Monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of central nervous system , orb) Diagnosing in clinical situations where the patient is in immediate danger.

Is this device used solely to illuminate the patient's body, with light in the visible or near infra-red spectrum?

Does this device require any procedure that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode and route of administration?

Is this device intended to be used principally with wounds which have breached the dermis?

Is this device intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent?

Is this a blood bag?

Can this device be connected to an active device in Class II or a higher class?

Is this device intended for channeling or storing body liquids or tissues, liquids, or gases for the purpose of eventual infusion, administration or introduction into the body?

Does the treatment of this device consist of filtration, centrifuging or exchanges of gas or of heat?

Is this device intended to be connected to an active medical device in Class II or a higher class?