Serial No.

Name of the product

Classification code

Product Description

1

Head nail

6810

This product is usually an assembly of a main body, a base, O-rings and a rubber cap. Only the main body will be in contact with the human body. The main body shall be made of stainless steel or titanium alloy materials specified in ISO 5832-1, ASTM F899 and ISO 5832-3. The product is used in conjunction with a skull fixator to fix the patient's head and neck at a specific position during a surgical procedure in which the skull undergoes a severe repair operation. The product is a non-implant and can only be used during the operation. It has temporary contact with the human body and will be immediately removed after the surgery.

2

Tools for spinal surgery

6810

Spinal surgery tools include bone chisels, rongeur forceps, scrapers, exciters, bone files, planers and reamers. These products should be made of stainless steel materials complying with ISO 5832-1 or ASTM F899. Spinal surgery tools are used to assist the internal fixation during the treatment of spinal fractures and the restoration of fractures so as to reconstruct anatomical relationships and provide immediate stability.

3

Spine endoscopic surgical instruments

6810

Relevant products include grasping pliers, nucleus pulposus forceps, basket punches, bone rongeurs, flexible grasping forceps, scissors, work cannulas, dilators, trephine drills, trephine drill handles, trephine drill protective sleeves, strippers, spinal chisels, surgical instrument displacement restrictors, bone files and guide wires. They are not used in conjunction with active instruments. The products shall be made of stainless steel materials conforming to YY/T 0294.1 or ASTM F899. Spinal endoscopic instruments are used for spinal endoscopy and surgery.

4

Joint endoscopic surgical instruments

6810

These products can include drill limiters, screwdrivers, scalpels with hooks, hollowed hole saws, guides, drill bits, non-eccentric femur aiming devices, conical screwdrivers, preset screwdrivers, guide pins, screw guide pins, screw opening devices, depth gauges, femur screwdriver opening devices, femur aiming devices, general purpose handles, semi-circular files, cartilage holding devices, posterior tibial aiming devices, posterior femoral aiming devices, plate inserters, tissue holders, ligament tensioners, ligament finishing devices, tendon rulers, torsion handles, tendon finishing plates, tendon bone holders, probes, curettes, strippers, obturators, screw taps, awls, working sheaths, guide exchange rods, micro-hooks, suction pipe sheath for arthroscopy, drill guide for patella bone, core for puncture sheath, threaders, knot pushers, bone hammers, drills, wire tapping knifes, arthroscope scissors, deep gauges, holders, guide pins, quick dilators, hammers with nylon head, replaceable nylon heads, pliers, bougies, rivet implanters, crochets, puncturing needles and puncturing needle cannulas. Parts that are in contact with the human body should be made of stainless steel or titanium alloy materials stipulated in the ISO 5832-1, ASTM F899 and ISO 5832-3 standards. These products are not used in conjunction with active instruments. They are suitable for the arthroscopic surgery of wrist, elbow, shoulder, knee, hip and ankle.

5

Medical instruments for surgeries involving percutaneous endoscopic lumbar discectomy

6810

The product consists of a dilator, a guide rod, a pair of nucleus pulposus forceps, a gauge, a protective cannula, a trephine drill, a nerve retractor, a handle, a hammer, a pair of rod holding forceps and a rotatable universal kit for cervical and spinal surgeries. Parts that are in contact with the human body should be made of stainless steel complying with the YY/T 0294.1 or ASTM F899 standard. It is not used in conjunction with active instruments. It is suitable for use in intervertebral disc inspections or surgeries.

6

Surgical instruments used with diskoscope

6810

The product consists of a dilator, a working cannula, a probe, a trephine drill, an adapter, a catheter, a handle, a spinal sheath and a pair of forceps. The human body contacting part is made of stainless steel that meets the provisions of YY/T 0294.1 or ASTM F899. It is used in conjunction with a diskoscope and is suitable for spinal disease examination and treatment.

7

Infant skull orthopedic fixator

6810

The product consists of a casing, filling materials/pads and fixtures. The product is suitable for the treatment of infants that are 3-18 months old and suffer from moderate or severe non-bone fusion oblique head deformities, including infants with an oblique head, a flat head and a boat-shaped head. By applying a moderate pressure to the protrusion area of the skull, it can improve the symmetry and shape of infant skulls. It is also suitable for the auxiliary use by infants that are 3-18 months old and still suffer from moderate to severe deformity after a skeletal union corrective surgery, including infants with an oblique head, a flat head or a boat-shaped head.

8

Uterine manipulator

6812

Uterine manipulator:  it is generally a rod like instrument made of stainless steel and a polymer material.  provided in sterile. It can be used to changes uterus position during abdominal surgeries and can also be used to control, enhance and clean the uterus.

9

Pen type insulin syringe

6815

Pen type insulin syringe is composed of the dose adjustment knob, pen body, release button, lead screw, cartridge holder, cap and  dose display window, it does not include the drug or injection needle, all parts are not in contact with the drug liquid; Used together with the specific insulin and the injection needle for subcutaneous injection of insulin.

10

Operation microscope used in ophthalmology

6822

The product is generally composed of an optical system, a control system, a lighting system and a mounting system. In clinical applications, it can provide amplification and lighting functions to enhance visual effects during ophthalmic surgeries.

11

Image processor for electronic endoscopes

6822

The product is usually composed of a host machine and accessories. The accessories include a power cord, interface cables and a data keyboard. It is used in conjunction with electronic endoscopes and displays so as to process and relay the images collected by the electronic endoscope to the display.

12

Planer used in endoscopic surgeries

6822

This product usually consists of mainframe, handle and cutters and allows handle and cutter to rotate mechanically through motors. The product is intended for performing such operations as cutting and grinding of bone or soft tissue, etc. in endoscopic surgery. The industry standard YY/T 0955 Medical endoscopes-Endoscope surgical equipment: Shaver.

13

 Ultrasonic bone densitometer

6823

Ultrasound bone density meter uses the difference in ultrasonic conduction velocity and the attenuation of amplitude to reflect the bone mineral content, bone structure and bone strength in the human body. It mainly includes an ultrasonic transmitter circuit, a receiving circuit, a signal processing and display module as well as a recording module. It can be categorized into several models according to its design, technical parameters and additional auxiliary functions. According to the population distribution in the clinical database, it is suitable for populations at corresponding ages. It is used for superficial human bone density measurement. The product performance index should follow the applicable parts of the following reference standard: YY 0774-2010 Ultrasonic bone densitometer.

14

Operational probes for ultrasound treatments

6855

The product is used in conjunction with dental ultrasonic cleaning machines. The materials used in its body usually include stainless steel and titanium alloys. It is used in oral root canal treatments to help the repair of medullary wall and removal of obstacles at the opening of the root canal.  It can be categorized into several models and specifications according to the materials of the handle and head, type and size. The materials used in its body must conform to the relevant national and industry standards. Its performance indicators shall meet the applicable sections in the following standards such as the "Dental rotary equipments Coordinating dimensions" in YY 91010. Its basic principles, scope of applications, performance and compositions shall be the same as those of the products already in the market. The exemption does not include products that are different from the products already in the market in terms of materials, technology, design, working mechanism or functions.

15

Dental burs (non metal)

6855

It is a type of dental rotary equipments and is made of resin and polyether ether ketone(peek). Dental bur is composed of handle and head operating end; it can be divided into different types and specifications by material, type and size of the handle and head; it is used for drilling teeth in oral treatment. The product performance index adopts applicable part of the following reference standard, such as: YY 0761.1 Dentistry Diamond rotary instrument Part 1: Dimensions, requirements, marking and , YY 0302.1 Dental rotary instruments—Burs—Part 1: Steel and carbide burs, YY 0302.2 Dental rotary instruments—Burs—Part 2: Steel and carbide burs for polishment.

16

Drills for orthodontic anchorage operations

6855

It is a type of dental rotary equipments and consists of a handle and an operational head. The materials used in its body usually include stainless steel and titanium alloys that are appropriate for such applications. It is used before the implantation of orthodontic anchorage. By drilling holes in the cortical bone, it can determine the location for orthodontic anchorage implantation. It can be categorized into several models and specifications according to the materials of the handle and head, type and size. The materials used in its body must conform to requirements in relevant national and industry standards. Its performance indicators shall meet the applicable sections in the following standards, such as "Dental rotary equipments Technical conditions for steel and hard alloy dental drills” in YY 91064 and "Dental rotary equipments Coordinating dimensions" in YY 91010. Its basic principles, scope of applications, performance and compositions shall be the same as those of the products already in the market. The exemption does not include products that are different from the products already in the market in terms of materials, technology, design, working mechanism or functions.

17

Correction holder

6863

The product is made of medical grade polyvinyl chloride materials or medical silicones and is a non-customized product with a standard size. It is used in the later stage orthodontic treatment.

18

Hydrofluoric acid etching agent used in dental applications

6863

Usually it is composed of hydrofluoric acid, thickening agent, and may be divided into a number of models and specifications by composition, hydrofluoric acid content, and filling level, etc. It is used for tooth filling repair, cementation of orthodontics bracket, and erosion treatment of tooth surface before use of anti-caries materials. The product performance indicators adopt the applicable parts of the following reference standards, such as YY 9769 Dental Phosphatic Erosion Agent.

19

Temporary crown and bridge material

6863

The product can be a two-component paste, a powder solution, a one-component paste or a perform product. Its main components include polyacrylates, polyvinyl esters and polycarbonates. It is used in the dental provisional restoration. The product  performance index adopts applicable part of the following reference standard, such as: YY/T 0826 Dental temporary polymer-based crown and bridge materials. The exemption does not include products that are different from the products already in the market in terms of materials, technology, design, working mechanism or functions.

20

desensitizer

6863

It is usually supplied in single-composition or two-composition liquid, paste, and gel. Its main component is strontium fluoride. It is used to alleviate allergy symptoms of the teeth caused by dentin sensitivity.

21

Alloy for dental cutting operations

6863

Metal materials used in dental cutting operations include cobalt-chromium alloy and alloys of precious metals. It is used for the production of dental prostheses such as dental crowns and dental bridges that are processed through a CAD/CAM process. The materials used in its body and its performance indicators shall meet the requirements in relevant national and industry standards, such as the applicable section in GB 17168 "Dentistry Metal materials for fixed and removable repairs". The exemption does not include products used for the production of implants and accessories.

22

Uterine positioning handle

6866

The product consists of a handle, a trigger, a shaft and a clip-on connector. It is used for aiming of the uterus and positioning of the uterus, fallopian tubes and ovaries during endoscopic (laparoscopic) surgeries. It is also used for the delivery of dyes during surgeries requiring the staining of fallopian tubes.