Public procurement notice: Contract Notice
Published: 2017-05-05
Buyer: Public Health Institute University Clinic for Clinical Biochemistry — Skopje
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33692500
Submission deadline: 2017-06-05
Award criteria: Lowest price

Technical requirements: Reagents, Controls and Supplies for Immunological Analyzer Cobas е601 'or equivalent' and Cobas Emira 'or equivalent'
Part 16 Quantitative determination of concentration of degrading products for collagen type I (B-Cross Lapss) for immunological analyser Cobas е 601 "or equivalent";
Part 25 Control sample in determination at least for (CEA, tPSA, fPSA, AFP, BHCG, CA 125, CA 15-3, CA 19-9, CA 72-4, CYFRA 21-1, Ferritin, NSE) for immunological analyser Cobas е 601 "or equivalent";
Part 26 Control sample in determination at least for (CEA, PSA, S 100, Cortisol, DHEA S, Estradiol, FSH, fT3, fT4, HCG, BHCG) for immunological analyser Cobas е 601 "or equivalent";
Part 27 Control sample in determination at least for (folic acid, Osteocalcin, PTH, Vitamin D, Vitamin B12, Calcitonin, B Cross Laps, Ferritin, Total P1NP) for immunological analyser Cobas е 601 "or equivalent";
Part 28 Agent for diluting the samples for immunological analyser Cobas е 601 "or equivalent", packing of min. 16mL;
Part 29 Agent for diluting the samples for Troponin T hs for immunological analyser Cobas е 601 "or equivalent", packing of min. 16mL;
Part 30 Concentrated cleaning agent for immunological analyser Cobas е 601 "or equivalent", packing of min. 100 mL;
Part 31 Cups for samples applicative to immunological analyser Cobas е 601 "or equivlent" with volume of 2 ml +/- 5 %;
Part 32 Consumables — cuvettes with a volume of 400µl +/- 5 µl applicative to immunological analyser Cobas е 601 "or equivalent";
Part 33 Tips for pipetting of serum with volume 200µl +/- 5 µl, applicative to immunological analyser Cobas е 601 "or equivalent";
Part 34 Cleaning agent for measuring cell of immunological analyser Cobas е 601 "or equivalent", packing of minimum 380 mL;
Part 35 Agent for generating a signal when measuring for immunological analyser Cobas е 601 "or equivalent", packing of minimum 380 mL;
Part 37 Bin with dimensions 42 cm x 11 cm x 8 cm and capacity of 3,7 litres for immunological analyser Cobas е 601 "or equivalent";
Part 38 Agent for preparing the measuring cell of immunological analyser Cobas е 601 "or equivalent" packing of 2L to 4L;

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 impoused; 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. 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.