The US Food and Drug Administration [2005] No.239, the first batch of Category II medical device products that do not need to apply for the Medical Device Business License.
Classification code name
product name
Universal diagnostic instrument
Thermometer, sphygmomanometer
Physical therapy equipment
Magnetic therapy instrument
Medical materials and dressings
Medical absorbent cotton, medical absorbent gauze, medical sanitary mask.
Clinical inspection and analysis instrument
Household blood glucose meter, blood glucose test paper, pregnancy diagnosis test paper (early pregnancy test paper)
Medical polymer materials and products
Condoms, contraceptive caps
Ward nursing equipment and appliances
wheelchair
dressing
Medical sterile gauze