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Classification: 34320208 [AHB358002]

Preferred name 34-32-02-08 Transcatheter valve
Definition Implantation of a heart valve prosthesis using a catheter, which is introduced either via vessels (percutaneously endovascular) or transapically
Keywords Interventional heart valve Minimally invasive valve replacement
IRDI 0173-1#01-AHB358#002
Already on the watchlist: 0 of max. 4

BASIC Properties: Transcatheter valve

  • Net weight
  • Valuelist Risk class according to MDD / IVDD guidelines
  • Valuelist Suitable cleaning / disinfection procedures
  • Valuelist MRI compatibility
  • Valuelist sterility
  • Valuelist appropriate sterilization method
  • address of additional link
  • actuarial durability of heart valve prosthesis at 20 years
  • Diameter of tissue annular ring
  • Pharmacy-Product-Number
  • estimated durability of heart valve prosthesis
  • Valuelist Type of heart valve prosthesis
  • Health Industry Barcode
  • Valuelist Developer or inventor of heart valve prosthesis
  • max. storage temperature
  • effective orifice area of heart valve prosthesis in vivo
  • Valuelist MRI visible
  • Material of intracardiac or vascular implant
  • Valuelist allergenic potential
  • Valuelist Position of heart valve prosthesis
  • Valuelist Risk class according to MDR / IVDR guidelines
  • Rate of thrombo-embolic and haemorrhagic occurrences
  • actuarial durability of heart valve prosthesis at 15 years
  • Valuelist expected shelf life of the heart valve prosthesis
  • Valuelist repositionable
  • Valuelist position of the valve leaflets
  • Valuelist release mechanism
  • max. inner diameter of the native annulus
  • min. inner diameter of the native annulus
  • min. required access vessel diameter
  • outside diameter of the catheter insertion profile
  • inner diameter of the catheter insertion profile
  • flap size
  • Valuelist possible access routes
  • Valuelist type of implantation procedure
  • Valuelist material of the cardiac or vascular implant
  • Valuelist approved indication
  • HS-Code of the WCO
  • Customs tariff number
  • Name of SVHC substance
  • Valuelist Use of customs tariff number
  • Valuelist Type of customs tariff number
  • Manufacturer product root
  • Manufacturer product order suffix
  • Manufacturer product description
  • product article number of manufacturer
  • URI of manufacturer
  • Manufacturer product family
  • Valuelist Anticalcification of bioprosthesis
  • actuarial durability of heart valve prosthesis at 10 years
  • min. storage temperature
  • effective orifice area of heart valve prosthesis in vitro
  • Pharmaceutical central number
  • Valuelist designated sterilization method
  • Reference norm product
  • On-line reference security data sheet
  • Valuelist REACH registration present
  • Valuelist Contains substance according to SVHC
  • On-line reference REACH
  • Weight percentage of the contained substance (SVHC)
  • Product check date (SVHC)
  • Supplier product type
  • Supplier product order suffix
  • Supplier product description
  • Supplier product family
  • GLN of supplier
  • name of supplier
  • product article number of supplier
  • Supplier product root
  • GLN of manufacturer
  • URI of the product
  • Product type
  • GTIN
  • Manufacturer name
  • Brand
  • Supplier product designation
  • Manufacturer product designation
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