Tenders Are Invited For Efop-2.2.19-17-2017-00015 Device Acquisition in Hungary

Work Detail

Efop-2.2.19-17-2017-00015 Device Acquisition. For The State Heart Hospital, On The Basis Of The Project Efop2.2.1917201700015 Development Of Outpatient Specialist Services Of The State Heart Hospital Balatonfüred, The Delivery Of The Devices Specified In The Technical Specification, With Their Installation, Installation And Commissioning As Necessary, As Specified In The Technical Specification, Which Is Part Of The Public Procurement Documentation, And According To The Following Sub-Tasks: Part 1: 1 Top Category Cardiology Ultrasound Device + 4Vcd 4D Transthoracic Probe Part 2: 5 Pcs + Optional 2 Pcs 12-Channel Resting Ecg Device + Cart Part 3: 1 Examination Table As Specified In Detail In The Technical Documentation Forming Part Of The Public Procurement Document (Hereinafter: Kd). With Respect To The Offered Product, The Manufacturer Of The Product(S), Or The Manufacturers Authorized Representative In The Case Of A Foreign Manufacturer, The Detailed Product Description Containing The Technical Parameters Of The Product(S) Issued By The Hungarian Distributor. The Tenderer Draws Attention To The Fact That, In Case Of Suspicion Of Non-Conformity, Their Authenticity Must Be Verified With An Authentic Manufacturers Statement At The Tenderers Request. 4/2009 On Medical Devices Under The Bidding Manufacturer. (Iii. 17.) Eüm Decree § 4 (1) Paragraph C). Means A Natural Or Legal Person Defined In Point The Tender Product Description Means A Document Summarizing The Functional And Technical Parameters Of The Product. The Product Descriptions Must Include The Features Of The Offered Product In Such Detail That It Can Be Clearly Established That All The Features Required In The Professional Specification Are Present. The Tenderers Offer In The Given Part Of The Code Of Civil Procedure. It Is Invalid According To § 73, Paragraph (1), Point E), If The Offered Product(S) Does Not Meet One Of The Properties Prescribed In The Professional Specification Based On The Submitted Product Description(S), Or If Compliance Cannot Be Established Beyond Doubt. In Relation To All Offered Devices, The Conformity Of The Medical Device With The Mdr And The Manufacturers Declaration Of Conformity Prescribed In The Regulation On Medical Devices And If The Mdr (On Medical Devices, Directive 2001/83/Ec, Regulation 178/2002/Ec And Regulation (Eu) 2017/745 Of The European Parliament And Of The Council Of April 5, 2017 Amending Regulation (Ec) 1223/2009 And Repealing Council Directives 90/385/Eec And 93/42/Eec), And It Must Be Certified With A Ce Conformity Assessment Certificate Required Under The Medical Devices Ordinance. (Section 9 (2) Of Government Decree 16/2012 (Ii. 16)). If The Offered Product Does Not Belong To The Devices For Which The Existence Of The Ce Conformity Assessment Certificate Is Mandatory, Then Only The Manufacturers Declaration Of Conformity (Ec Conformity Declaration) Must Be Submitted For Those Products. Translation Of Manufacturers Declarations Of Conformity (Ec Conformity Declaration), Ce Certificates, Product Brochures In The Translation Of An Accepted Bidder.

Contact Information