Public procurement notice: Contract Notice
Published: 2017-05-06
Buyer: Public Health Institute University Clinic for Clinical Biochemistry — Skopje
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33696500
Submission deadline: 2017-05-23

Technical requirements: Reagents, Control Blood Samples and Expendable Material for Hematology Analyser Sysmex KX 21N AND XS 1000 ‘or an Equivalent’.
Part 1 Solution for dilution in 20L maximum package compatible with hematology analyser SYSMEX KX 21N and XS 1000 "or an equivalent".
Part 2 Reagent for lysis for the purpose of determining 3-part differentiation in 500ml maximum package compatible with hematology analyser SYSMEX KX 21N "or an equivalent".
Part 3 Reagent without cyanide for determining hemoglobin for the purpose of determining 5-part differentiation in 500ml maximum package compatible with hematology analyzer SYSMEX KX 21N "or an equivalent".
Part 4 Reagent for fluorescent colouring of leukocytes for the purpose of determining 5-part differentiation in 42ml maximum package compatible with hematology analyser SYSMEX KX 21N "or an equivalent".
Part 5 Reagent for lysis for the purpose of determining 5-part differentiation in 5l maximum package compatible with hematology analyser XS 1000 "or an equivalent".
Part 6 Alkaline detergent for cleaning in 50ml maximum package compatible with hematology analysers SYSMEX KX 21N and XS 1000 "or an equivalent".
Part 7 Control blood sample — normal level (minimum parameters WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, P-LCR, PDW, PCT) in 4.6ml maximum package, compatible with hematology analyser SYSMEX KX 21N "or an equivalent".
Part 8 Control blood sample — low level (minimum parameters WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, P-LCR, PDW, PCT) in 4.6ml maximum package, compatible with hematology analyser SYSMEX KX 21N "or an equivalent".
Part 9 Control blood sample — high level (minimum parameters WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, P-LCR, PDW, PCT) in 4.6ml maximum package, compatible with hematology analyser SYSMEX KX 21N "or an equivalent".
Part 10 Control blood sample — normal level (for minimum parameters WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT(#), LYMPH(#), MONO(#), EO(#), BASO(#), RDW-SD, RDW-CV, MPV, P-LCR, PDW, PCT) in 1.5ml maximum package compatible with hematology analyser SYSMEX XS 1000 "or an equivalent".
Part 11 Control blood sample — low level (for minimum parameters WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT(#), LYMPH(#), MONO(#), EO(#), BASO(#), RDW-SD, RDW-CV, MPV, P-LCR, PDW, PCT) in 1.5ml maximum package compatible with hematology analyser SYSMEX XS 1000 "or an equivalent".
Part 12 Control blood sample — high level (for minimum parameters WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT(#), LYMPH(#), MONO(#), EO(#), BASO(#), RDW-SD, RDW-CV, MPV, P-LCR, PDW, PCT) in 1.5ml maximum package compatible with hematology analyser SYSMEX XS 1000 "or an equivalent".
Part 13 Thermal paper, minimum dimensions 57mm x 30m for hematology analyser SYSMEX "or an equivalent".
Part 15 Solution for dilution in 20L maximum package compatible with hematology analyser MEDONIC M "or an equivalent".

Eligibility requirements: — Document for registered activity — DRD form or certificate of registered activity; — Decision for wholesale trade with medical supplies under the Law on Medicines and Medical Appliances; — A statement by the economic operator that it has not been imposed a legally valid court decision for participation in criminal organization, corruption, fraud or money laundering for the last 5 years; — A certificate by a competent authority that a bankruptcy procedure has not been initiated; — A certificate by a competent authority that a liquidation procedure has not been initiated; — A certificate by a competent authority from the country where that economic operator is registered for paid taxes, contributions and other public duties; — A certificate by the Register of sentences for committed crimes of legal entities that a secondary sentence prohibition on participation in open call procedures, awarding public procurement contracts and contracts for public private partnership, has not been imposed; — A certificate by the Register of sentences for committed crimes of legal entities that a secondary sentence temporary or permanent prohibition on performing a certain activity has not been imposed; and — A certificate that a misdemeanor sanction resulting in prohibition for practising profession, performing activity or EN Standard form 02 — Contract notice 6 / 16 EN Standard form 02 — Contract notice 7 / 43 duty, i.e. temporary prohibition for performing a particular activity has not been imposed by a legally valid court decision. For registered medical supplies: — For the offered goods the economic operator must have provided an Approval for marketing of medical device or temporary or permanent Authorization for parallel imports, under the Law on Medicines and Medical Devices. For unregistered medical supplies: — For the offered goods the economic operator must have provided a document that authorizes the import (Approval for intervention import) under the Law on Medicines and Medical Devices. For registered medical supplies: — a Decision for marketing of medical device or temporary or permanent Authorization for parallel imports, under the Law on Medicines and Medical Devices. For unregistered medical supplies: — Import License (Authorization for Intervention Import) under the Law on Medicines and Medical Devices.
For registered medical supplies: — For the offered goods the economic operator must have provided an Approval for marketing of medical device or temporary or permanent Authorization for parallel imports, under the Law on Medicines and Medical Devices. For unregistered medical supplies: — For the offered goods the economic operator must have provided a document that authorizes the import (Approval for intervention import) under the Law on Medicines and Medical Devices. For registered medical supplies: — a Decision for marketing of medical device or temporary or permanent Authorization for parallel imports, under the Law on Medicines and Medical Devices. For unregistered medical supplies: — Import License (Authorization for Intervention Import) under the Law on Medicines and Medical Devices.
For registered medical supplies: — For the offered goods the economic operator must have provided an Approval for marketing of medical device or temporary or permanent Authorization for parallel imports, under the Law on Medicines and Medical Devices. For unregistered medical supplies: — For the offered goods the economic operator must have provided a document that authorizes the import (Approval for intervention import) under the Law on Medicines and Medical Devices.
For registered medical supplies: — a Decision for marketing of medical device or temporary or permanent Authorization for parallel imports, under the Law on Medicines and Medical Devices. For unregistered medical supplies: — Import License (Authorization for Intervention Import) under the Law on Medicines and Medical Devices.