Public procurement notice: Contract Notice
Published: 2016-11-25
Buyer: University clinic of pediatric surgery
Country: MK
Region: Poranešnata jugoslovenska Republika Makedonija
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33100000 | 33140000: Medical consumables
Estimated value: 3200000 MKD
Submission deadline: 2016-12-07
Award criteria: Lowest price

Technical requirements: Immunochromatographic tests, cartridges, reagents and supplies for acid — base devices and hematological analyser.
Public Health Institution University Clinic for Pediatric Surgery ul. Majka Tereza br. 17 1000 Skopje, Republic of Macedonia.
Immunochromatographic tests, cartridges, reagents and supplies for acid — base devices and hematological analyser.
Washing and waste Cartridge applicative device Rapid Point 400 or equivalent and Rapid Point 500 or equivalent.
Automatic quality control cartridge applicative device Rapid Point 400 or equivalent and Rapid Point 500 or equivalent.
Heparinized syringes from 1ml to ± 0,2 % deviation, RAPID POINT 400 device applicative or equivalent and Rapid Point 500 or equivalent.
Thermal paper width 57mm ± 0,5 % and minimum length 40m, Rapid Point 400 device applicative or equivalent and Rapid Point 500 or equivalent.
Reagent for lysis of erythrocytes applicative of hematological Medonic M counter 20 maximum of 5 L or equivalent.
Heparinized capillaries made of PET (polyethylene) with a volume of 150μl ± 0,2 % compatible to Gem Premier 3000 device or equivalent.
Heparinized syringes made of PET (polyethylene) with a volume of 2ml ± 0,2 % compatible to Gem Premier 3000 device or equivalent.
Immunochromatic quick test for the determination of procalcitonin in serum and plasma, for the diagnosis and control of bacterial infections and sepsis within 30min. Each test should include: test and reference map disposable pipette.
Cleaning solution with a volume of min. 0,5 to max. 1 L for hematologic counter Humacount TS 30 or equivalent.
Lysis solution (dispersion formative elements of blood) volume from min. 0,5 to Max.1 L, of hematologic counter Humacount TS 30 or equivalent.
Blood control with normal values for hematology counter Humacount TS 30 or equivalent, with a volume of min.1 to max. 2 ml investigating at least the following parameters: leukocytes, lymphocytes, MID, granulocytes, erythrocytes, hemoglobin, hematocrit, thrombocytes, RBC/GR, MCV/VGM, MCH/TCMH, MCHC/CCMH, RDW/IDR-CV, MPV/VPM.
Immunochromatographic tests, cartridges, reagents and supplies for acid — base devices and hematological analyser.

Eligibility requirements: — Statement of the economic operator proving that in the last 5 years has had an effective sentence for participation in a criminal organization, corruption, fraud or money laundering; — Certificate that a bankruptcy procedure has not been initiated by the competent body; — Certificate that a liquidation procedure has not been initiated by the competent body; — Certificate of paid taxes, benefits and other public duties, issued by the competent body in the country where the economic operator is registered; — Certificate from the Registry of penalties for committed acts of crime by legal entities that the economic operator has not been issued an additional penalty of a ban on participating in procedures for public call for bids, for awarding public procurement contracts and for contracts on public — private partnership; — Certificate from the Registry of penalties for committed acts of crime by legal entities that the economic operator has not been issued an additional penalty of a temporary or permanent ban on performing a certain activity. To prove the ability to perform professional activity, the economic operator should submit a document for registered activity as proof that it is registered as a legal entity for performing the activity related to the subject of the contract or proof that they belong to a professional association accordance with the regulations of the country where it is registered. Decision to be entered in the register of legal entities for wholesale of medical devices issued by the Agency for Medicines and Medical Devices, according to the Law on medicines and medical devices Article 126 paragraph 2. Decision (valid) granting approval for placing the medical device on the territory of the Republic Macedonia or approval for parallel import or temporary approval for parallel import issued by the Ministry of Health / Agency for Medicines of the Republic Macedonia. The subject of procurement — tests, reagents and consumables should be approved for marketing in the Republic of Macedonia according to the Law on Medicines and Medical Devices, that are registered or approved for parallel imports.
To prove the ability to perform professional activity, the economic operator should submit a document for registered activity as proof that it is registered as a legal entity for performing the activity related to the subject of the contract or proof that they belong to a professional association accordance with the regulations of the country where it is registered. Decision to be entered in the register of legal entities for wholesale of medical devices issued by the Agency for Medicines and Medical Devices, according to the Law on medicines and medical devices Article 126 paragraph 2.
Decision (valid) granting approval for placing the medical device on the territory of the Republic Macedonia or approval for parallel import or temporary approval for parallel import issued by the Ministry of Health / Agency for Medicines of the Republic Macedonia. The subject of procurement — tests, reagents and consumables should be approved for marketing in the Republic of Macedonia according to the Law on Medicines and Medical Devices, that are registered or approved for parallel imports.
Decision (valid) granting approval for placing the medical device on the territory of the Republic Macedonia or approval for parallel import or temporary approval for parallel import issued by the Ministry of Health / Agency for Medicines of the Republic Macedonia.
The subject of procurement — tests, reagents and consumables should be approved for marketing in the Republic of Macedonia according to the Law on Medicines and Medical Devices, that are registered or approved for parallel imports.