Request For Information - Ivd Medical Devices - Osmometers

Background And Purpose Of The Information Request Fimlab Laboratoriot Oy Is Preparing The Purchase Of Osmometers Suitable For A Clinical Laboratory. The Purpose Of This Information Request Is To Survey Ivd Medical Devices On The Market. The Information Request Is Used To Support Procurement Preparation. This Is Neither A Request For Tender Nor A Request For Information To Oblige The Procuring Entity To Carry Out The Tender. Product Groups To Be Procured The Planned Procurement Includes The Following Product Groups: Ce-Marked Osmometers Intended For Professional Use That Measure The Lowering Of The Freezing Point, Which Meet Both Up-To-Date Eu Legislation ((Eu) 2017/746) And National Legislation (Laws 719/2021 And 629/2010) Ivd For Medical Devices. The Purpose Of The Request For Information Is To Map Both Automatic Devices That Analyze Multiple Samples In A Series And Devices That Analyze Individual Samples. Requested Information From The Supplier: Suppliers Basic Information:• Company Name And Company Id Number• Contact Person And Contact Information• Brief Description Of The Companys Operations And Experience As A Supplier Of Osmometers In Finland Or Other Nordic Countries (Including Equipment, Reagents, Accessories And Maintenance).Osmometers:• Ce Marking, Manufacturers Declaration Of Conformity And Quality Management System Certifications • Quality Management System Standards Followed By The Distributor (If Applicable) • Purpose Of Use Of The Device As Described In The User Manual • Validated Sample Formats For The Device As Described In The User Manual • Does The Manufacturer/Distributor Offer An Automatic Device Capable Of Analyzing Several Samples In A Series? Make And Model Of The Device:• Does The Manufacturer Have, In Addition To The Previous One, A Device That Can Analyze The Sample As An Individual Sample? Make And Model Of The Device:• Is The Automatic Device Able To Pipette The Sample From The Primary Tube?• Is It Possible To Identify The Primary Tube From The Barcode? Maximum Number Of Characters In The Code? • Possibility Of Device Connection To The Laboratory Information System?• Country Of Manufacture Of The Device/Devices?• Performance Of The Device/Devices - Measurement Range, Measurement Accuracy And Repeatability For Each Applicable Sample Type?• Standardization Of The Device/Devices - Manual Or Automatic? Standardization Interval According To The Manufacturers Instructions?• Manufacturers Instructions On User Maintenance Of The Device (Including Time Required For Maintenance)?• Manufacturers Instructions On Periodic Maintenance Of The Device?• Does The Manufacturer/Distributor Have A Maintenance Organization In Finland?• List Of Supplies And Reagents Needed By The Device. A Potential Bidder Can Participate In The Request For Information By Sending The Requested Information No Later Than 20.3 At 12:00. The Information Is Sent By E-Mail To The Address: Tättä[email protected]. Title Your Message As Follows: Information Request 600231 / Osmometers (Company Name).