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Medical Device Classifications Released by NMPA

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The NMPA Medical Device Standardization Administration released the “Medical Device Classification Results for 2020-2021”. The document identifies 155 Class III, 505 Class II and 143 Class I medical devices, and 20 combination products.

The Medical Device Classification List

The devices identified by the Medical Device Classifications Results include but not be limited to the following:

Class III

  • Disposable endoscope suture system+C2:C31
  • Arterial thrombectomy balloon catheter
  • Vertebroplasty kits
  • acellular dermal matrix
  • heart valve biopatch
  • Prostate urethral stent system
  • Absorbable lifting thread for plastic surgery
  • Modified sodium hyaluronate gel for injection
  • Pump-type central venous catheter irrigator
  • Percutaneous gastrostomy kit
  • X-ray bone age detection equipment
  • deep brain electrodes
  • Disposable percutaneous renal dilators and accessories
  • Disposable endoscopic cutting stapler and components
  • Disposable titanium-nickel memory alloy internal anal fistula stapler

Class II

  • Disposable nasal stent
  • Disposable endoscopic compression balloon
  • Accessory kits for endoscopic surgical instrument control systems
  • visual nasoenteric tube
  • non-absorbable surgical sutures
  • Biliary dilation catheter
  • Skull drill
  • Disposable sterile digestive traction clip
  • Disposable small intestine isolation protection device
  • Disposable trigeminal neuralgia compression balloon device
  • Flushable cutting
  • Disposable sterile craniotomy fixator

Class I

  • Nasal introducer
  • Surgical power handle connection cannula
  • Dialysis care package
  • Neck stoma leak proof silicone
  • External drainage tube
  • External drainage tube
  • Oral abutment substitute
  • Negative pressure drainage
  • Ophthalmic surgery drainage
  • Suspension training system

Combination products

  • Intragastric weight loss balloon system
  • Sodium hyaluronate composite microspheres for injection
  • Chlorhexidine oral desensitization antibacterial solution
  • Protein scaffolding materials
  • wound healing gel dressing

If you have any questions about Medical Device Classifications, please contact us at info@chinameddevice.com.

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