Instructions for use

  • > instruction for use ASSKEA proVisio® M28 Dutch
  • > instruction for use ASSKEA proVisio® M28 French/Italian
  • > instruction for use ASSKEA proVisio® M28 German/Englisch
  • > instruction for use ASSKEA proVisio® M28 Polish
  • > instruction for use ASSKEA proVisioBasic /ASSKEA proVisioBasicbattery
  • > instruction for use M- and S-series Dutch
  • > instruction for use M- and S-series French/Italian
  • > instruction for use M- and S-series German/English
  • > instruction for use M- and S-series Polish
  • > instruction for use ped series
  • > instruction for use procuff-series
  • > Reprocessing instruction for holder external canister “Bag“

Notes on EMC

  • > notes on electromagnetic compatibility ASSKEA proVisio® M28
  • > notes on electromagnetic compatibility M- and S-series
  • > notes on electromagnetic compatibility ped M and S

Certificates

  • > certificate EN ISO 13485 SLG (2026/01/13)
  • > MDD certificate PCBC
  • > MDR certificate
certificate EN ISO 13485 for design, development, manufacture and distribution of medical aspirators > Download: certificate EN ISO 13485 SLG (2026/01/13)

Declarations of conformity

  • > Declaration According to Article 22 MDR Accessory Sets
  • > Declaration According to Article 22 MDR Procedure Pack
  • > Declaration of conformity Bag and OneWay
  • > declaration of conformity cuff aspirators
  • > Declaration of conformity holder canisters
  • > Declaration of conformity PRO-II canister
  • > Declaration of conformity reusable canisters
  • > declaration of conformity secretion aspirators
  • > declaration of conformity secretion aspirators for children
  • > declaration of conformity Suprasorb CNP endo
  • > Declaration of conformity tube sets
  • > declaration of conformity wound aspirators
> Download: Declaration According to Article 22 MDR Accessory Sets

Return of goods

  • > `Used Medical Device´ label
  • > product return form

ASSKEA Li-Ion Battery Pack

  • > ASSKEA Li-Ion Akkupack Certificate of Conformity
  • > ASSKEA Li-Ion Akkupack Material Safety Date Sheet
  • > ASSKEA Li-Ion Akkupack REACH Test Report
  • > ASSKEA Li-Ion Akkupack RoHS Test Report
  • > ASSKEA Li-Ion Akkupack UN38.3 Test Summary Report

Miscellaneous

  • > INQA
  • > top 100
final certificate INQA audit > Download: INQA