Class II medical device products include

The second class of medical equipment products include:

1, thermometer, sphygmomanometer (various types), electronic blood pressure pulse meter, dynamic blood pressure monitor;

2, sound, light, electricity, magnetic stimulator, acupuncture needles;

3, magnetic therapy machine, magnetic induction electrotherapy machine, low-frequency electromagnetic integrated therapy machine, specific electromagnetic wave therapy machine, magnetic therapy apparatus;

4

4, hemostatic sponge condoms, contraceptive caps sterile medical gloves;

5, medical vaginal scrubber, medical vaginal douche;

6, vacuum blood collection tubes, blood collection needles, laser blood collection machine;

7, medical suture needles (without line), automatic urine analyzers and test strips, disposable catheters non-absorbable sutures (with/without needles);

8, hearing aids, infusion pumps, syringe pumps;

9, cardiac diagnostic instruments, electroencephalographic diagnostic instruments, electromyographic diagnostic instruments, other bioelectrical diagnostic instruments;

10, diagnostic fiberoptic endoscopes (upper gastrointestinal endoscopes, colonoscopes, colonscopes, bronchoscopes), observation of rigid-tube endoscopes (laryngoscopes, rhinoscopes, cystoscopes, uteroscopes, proctoscopes, amniotic fluid scopes);

11, multifunctional ultrasound monitor, ultrasound mother/fetal monitor, ultrasound obstetric monitor, fetal monitor;

12, patient monitor (monitoring parameters including cardiac, oxygen saturation, non-invasive blood pressure, pulse, temperature, respiration, end-of-expiratory carbon dioxide) anesthesia gas monitor, respiratory function monitors, sleep evaluation system, labor and delivery monitors;

13, abortion suction device, negative pressure suction device.

Legal basis: "Supervision and management of medical devices" Article 64

"Medical device license" and "medical device business record voucher format by the State Food and Drug Administration unified development.