Bulgaria – Medical consumables – “Supply of medical devices for invasive cardiology for the needs of ‘MBAL PAZARDZHIK’ AD 2026–2027 – not offered”

Opportunity description

Subject of the public procurement: The object of the procurement is periodically recurring supplies of medical devices for invasive cardiology for the needs of MBAL Pazardzhik AD under separate lots, described in detail in the Technical Specification, which constitutes an integral part of the documentation for conducting the procedure. The Technical Specification consists of 16 (sixteen) separate lots. Each candidate may submit only one tender, including the performance of one, several or all of the separate lots under the attached specification. Completeness of the lot is a mandatory condition; if a tender for a nomenclature item is missing, the entire lot will not be evaluated. The quantities specified in the Technical Specification for the individual nomenclature items are estimated, determined on the basis of the contracting authority’s previous two-year consumption, and should not be interpreted as an obligation of the Contracting Authority for either a minimum or a maximum total quantity (during the term of the contract) of the specified products under the respective nomenclature items. For the term of the contract, the Contracting Authority reserves the right to change the quantities specified in the Technical Specification according to its needs and in view of the number of patients, but they are in performance of the subject of the contract. Period for performance of the public procurement: until 25.02.2028, starting from the date of conclusion of the public procurement contract, through periodic deliveries pursuant to prior requests by type and quantity. If, following its expiry, no new contracts under the Public Procurement Act with the same subject have been concluded, its validity shall be extended under the same conditions until a new procedure under the Public Procurement Act with the same subject is conducted, but for no more than 6 months. The Contracting Authority may terminate the concluded contract early by written notification—without notice /without penalties and compensation being due/ under the conditions of Art. 7, para. 3 of Council of Ministers Decree No. 146 of 09.06.2015 on the establishment of a Central Purchasing Body for the Healthcare sector. Technical conditions for performance of the public procurement: Requirements for the medical devices (consumables) offered: - the medical devices offered must fully comply with the relevant technical characteristics specified in the Technical Specification; - the medical devices offered must have an issued CE certificate and/or a Manufacturer’s Declaration of Conformity with the applicable EU Directive and must comply with the Medical Devices Act and the implementing regulations. If a proposed product does not comply with the Contracting Authority’s requirements, the respective tender will not be admitted for consideration (the participant will be excluded from participation in the respective separate lot). For lots No. 12 to No. 16—the candidates must provide Samples—specimens for all devices for which they are participating. Each specimen must be marked with the number from the specification to which it corresponds and the company mark (identifying inscription) of the candidate company. The manufacturer of the medical devices must be evident from the specimens. The specimens shall be submitted in separate packaging bearing an inscription. The specimens will be used to determine the compliance and quality of the offered product with the Contracting Authority’s requirements; if they remain unopened, they will be returned to the participant; if their original condition is altered, they will be paid for by the Contracting Authority. The specimens shall be delivered to “MBAL Pazardzhik” AD, Pazardzhik, 15 Bolnichna St., Dean’s Office, floor 2, Registry Office. ​​​​​​​ PTCA guidewire, 0.014'', 180/300cm; straight and J tip; good shape memory; radiopaque section—3cm, tip load—0.5G, spring length—20cm; SLIP COAT coating on the spring; PTFE coating on the shaft pcs. 50 Balloon material—polyamide; Markers—two; Tip profile—0.017"; Nominal pressure (NP)—8 bar; rated burst pressure (RBP)—up to 19 bar; Guide catheter diameter—5F (minimum inner diameter 1.42 mm); Catheter length—min. 138 cm; RX lumen length—min. 27 cm; compatible with 0.014" guidewire; shaft size—proximal 1.9 F, distal 2.8 F; Balloon diameters—at least 1.5, 2.0, 2.25, 2.5, 2.75, 3.0, 3.25, 3.5, 4.0; Balloon lengths—at least 10, 15, 20, 25, 30, 35, 40 mm—pcs. 100 PTCA balloon catheter—MR, to provide a low profile and smooth transitions at the joints for easy passage and withdrawal. Flexible and durable for navigation through curved anatomical sections, as well as for passage through tight lesions and stent struts. SoftLeap balloon material, which is found in the 1.5 and 2.0 mm balloons for improved softness and retrievability. Tapered TrakTip tip with a 0.17 lesion entry profile for excellent crossability. Excellent dye flow for improved visibility, balloon compatibility with 6 F guide catheters Lengths—9,12,15,20,25,30 mm; Balloon diameter—1.5/2.0/2.25/2.5/2.75/3.0/3.25/3.5/3.75/4.0mm; Nominal pressure—6 ATM—pcs. 100 Sterile balloon for counterpulsator, 7.5 Fr, 40 CC volume; insertable length 72.3 cm; gas passage area—0.0048SQIN; lumen size 0.030''; inflation/deflation time—446 msec guidewire size 0.025" x 145 cm 3mm J PTFE; lumen with inner lining—polyamide; catheter holder sheath—polyurethane; catheter holder with cooperative opening; does not contain pure steel; single use.—pcs. 10 Cuting ballon—guidewire: 0.014", RX catheter, Scoring element: nitinol, three spirals, low profile ~2.7f; balloon: PEBAX, semicompliant. shaft:—5F; 6F guide catheter; working length—137cm; balloon markers: 2 swaged; balloon diameter 2–3.5mm; balloon length 10–20mm—pcs. 5 Pericardiocentesis set including an 18G, 120 mm puncture needle. Contains: - Puncture needle 18G, 120 mm - Drainage catheter with stylet - Intradyn F6 dilator with split introducer sleeves - Sterican cannula, size 0.9x70mm - Cutfix disposable scalpel - Secretion bag with a volume of 1500 ml - Pump device - Omnifix syringe with luer lock, 50ml - Omnifix syringe with luer lock, 10ml - Diagnostic guidewire J3—pcs. 5 Original extension, 25cm long, with luer-lock attachment, material—PVC, diameter 1.5x2.7 mm—pcs. 50 1. Three-layer, sterile angiography set, suitable for femoral and radial access, for single use. Sterilization method—irradiation. Contains: - 2 pcs. cellulose towels 18x25 cm - 2 pcs. surgical drapes 150x150cm, with absorbent section 75x150cm. Made of viscose 23g/m2 and polyethylene film 55 microns, absorption in the critical area 1.1 g/dm2 - 1 pc. absorbent towel 56x80cm - 1 pc. adhesive drape 50x50cm—three-layer. Made of nonwoven textile—viscose 23 g/m2, nonwoven polypropylene 12 g/m2, polyethylene film 40 microns and rubber-based adhesive material, absorption 1.1 g/dm2; - 1 pc. angiography drape 240x330cm with a special absorbent and impregnating coating, with two openings 5x7cm and two openings 7x9cm. Made of nonwoven textile—viscose and polyester 50 g/m2, polyethylene film 40 microns and adhesive material based on synthetic rubber. Absorption capacity in the critical area 2.98 g/dm2—sets 200 pcs. 2. Disposable sterile gowns made of impermeable SMS nonwoven breathable material, supplied with two towels, in sizes—L, L-L, XL, XL-L. Gown material polyethylene 35 g/m², front reinforcement with nonwoven polypropylene with polyethylene film 33 g/m² and on the sleeves with nonwoven polypropylene with polyethylene film 40 g/m², cuff and tie material—polyamide. Ultrasonically attached sleeves to increase impermeability. Lightweight for additional comfort; T-shaped design for a good fit. In compliance with standards EN13795—Standard Performance and EN13795—High Performance. Sterilization method—EtO.—pcs. 400 3. Flexible postoperative wound dressing with an “all-in-one” border, waterproof, barrier against bacteria >25nm. Ultra-absorbent material and transparent film for checking wound maceration without removal. Flexible backing with flex-cut technology for stretching in all directions. With Safetac technology, minimizing damage to the surrounding skin upon removal. Size 10x15 cm.—pcs. 100 1. Angiography set: Sterile angiography set for radial and femoral access containing: sterile disposable angiography drape for radial and femoral access made of nonwoven textile/SMS/, three-layer, size 380/240cm, with two radial openings—oval—12x7.6 cm, two femoral openings with a diameter of 12.7 cm, transparent areas on both sides measuring 63/350cm; additional highly absorbent layer around the openings, with two standard sterile disposable gowns made of SMS waterproof breathable nonwoven material with an intermediate microfiber layer preventing the passage of liquids and bacteria, low linting and high tear resistance, raglan sleeves and Velcro ties around the neck, edges joined by bonding, packed in two-layer packaging, with two towels and sizes L—length 123 cm and XL—length 135 cm.—sets 3600 pcs. 2. Sterile, disposable, two-layer drape made of nonwoven textile, size 112x150cm—pcs. 3600 Procedure: open. Estimated value: 163,000 EUR. Review the original TED notice for the complete requirement, lots, amendments and attachments.