Class I refers to medical devices whose safety and efficacy can be ensured through routine management. Generally by the City Food and Drug Administration to approve the registration certificate issued.
Class II refers to its safety, effectiveness should be controlled medical devices. Generally by the provincial Food and Drug Administration to approve the registration certificate issued.
Class III refers to, implanted in the human body; used to support, maintain life; potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices.
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Blood glucose test strips belong to "6840 Clinical Test and Analysis Instruments" according to "Use"
Medical Devices Category:
/gyx02302 /flml.htm
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For example, the more commonly used Johnson & Johnson Blood Glucose Test Strips (trade name: Stable Ho)
Registration Certificate No.: State Food and Drug Administration Measures (in) No. 2401197 of 2010
2010 means: Approved in 2010
2 means: Class II Medical Devices
40 means: Class II Medical Devices
This is the first time that a medical device is classified as a Class I medical device, and it is the first time that a medical device has been approved. /p>
40 means: 6840 clinical test analyzers
1197 means: serial number.