Public procurement notice: Contract Notice
Published: 2018-10-03
Buyer: Public Health Institute University Clinic for Clinical Biochemistry - Skopje
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33695000
Award criteria: Lowest price

Technical requirements: Reagents, Controlls and Consumable Material for a Hematologic Analyzer Sysmex, Medonic and Coagulometer BFT II “or Equivalent”
— Lot 1: Dilution solution in a maximum 20L package compatible for hematologic analyzer Sysmex XP300 and XS 1 000 “or equivalent”,
— Lot 2: A lysis reagent to determine 3 - part differentiation in a maximum package of 500 ml compatible for hematological analyzer Sysmex XP 300 “or equivalent”,
— Lot 3: Reagent without cyanide for determination of hemoglobin for the purpose of determining 5-part differentiation in A maximum package of 500 ml compatible for hematological analyzer Sysmex XS 1000 “or equivalent”,
— Lot 4: Reagent for fluorescence staining of leucocytes for the purpose of determining 5-part differentiation in a maximum package of 42 ml compatible for hematological analyzer Sysmex XS 1000 “or equivalent”,
— Lot 5: Lysis reagent for determination of 5-part differentiation in a maximum package of 5L compatible for hematological analyzer XS 1000 hematologic “or equivalent”,
— Lot 6: Alkaline detergent for cleaning in a maximum package of 50ml compatible for hematological analyzer Sysmex XP 300 and XS 1000 “or equivalent”,
— Lot 7: Control blood - normal level (minimum parameters WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, P-LCR, PDW, PCT) in a maximum package of 4,6 ml compatible for haematological analyzer Sysmex XP 300 “or equivalent”,
— Lot 8: Control blood - low level (minimum parameters WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, P-LCR, PDW, PCT) in a maximum package of 4,6 ml compatible for haematological analyzer Sysmex XP 300 “or equivalent”,
— Lot 9: Control blood - high level (minimum parameters WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, P-LCR, PDW, PCT) in a maximum package of 4,6 ml compatible for haematological analyzer Sysmex XP 300 “or equivalent”,
— Lot 10: Control blood - 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 a maximum package of 1.5 ml compatible for hematological analyzers Sysmex XS 1000 “or equivalent",
— Lot 11: Control blood - 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 a maximum package of 1.5 ml compatible for hematological analyzers Sysmex XS 1000 “or equivalent",
— Lot 12: Control blood - 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 a maximum package of 1.5 ml compatible for hematological analyzers Sysmex XS 1000 “or equivalent",
— Lot 13: Thermo paper minimum size 57mm. x 30 m. for hematological analyzer Sysmex ''or equivalent'',
— Lot 15: Solution for dilution in a maximum 20L package compatible for haematological analyzer Medonic M “or 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 inpoused and, — a certificate that a misdemeanor sanction resulting in prohibition for practicing profession,performing activity or EN Standard form 02 — Contract notice 6/16 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.