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DatumŠtevilka zadeveProizvajalecMedicinski pripomoček
28.05.2026P301-22/2025Philips Medical Systems Nederland BV, NLPhillips Allura in Azurion
Posodobitev obvestila objavljenega januarja 2025
15.05.2026P301-198/2025MAQUET Cardiovascular LLC, ZDAHeartstring III Proximal Seal System
Posodobitev obvestila objavljenega avgusta 2025
15.05.2026P301-46/2026Philips Respironics, Inc., ZDATrilogy Evo; Trilogy Evo O2; Trilogy EV300
Posodobitev obvestila objavljenega marca 2026
Priloga 1
Priloga 2
15.05.2026P301-53/2026Vascutek Ltd., GBThoraflex Hybrid
Posodobitev obvestila objavljenega marca 2026
15.05.2026P301-72/2026B·R·A·H·M·S GmbH, part of Thermo Fisher Scientific, DEB·R·A·H·M·S PlGF Plus KRYPTOR
Posodobitev obvestila objavljenega aprila 2026
29.01.2026P301-21/2026Merivaara Corporation, FI
Merivaara Q-Flow surgical lights
Priloga 1
Priloga 2
Priloga 3
Priloga 4
Priloga 5
04.05.2026P301-84/2026CILITA Limited Liability Company (CILITA LLC), Russia
Reusable ophthalmic instruments
04.05.2026P301-85/2026ELLA-CS, s.r.o., CZSX-ELLA Stent Danis (Danis stent)
08.05.2026P301-86/2026BioFire Diagnostics, LLC, ZDA
BioFire Joint Infection (JI) Panel
11.05.2026P301-87/2026Philips Medical Systems Nederland BV, NLPhilips Azurion
11.05.2026P301-88/2026Philips Medical Systems Nederland BV, NL
Philips Allura and Azurion systems
12.05.2026P301-89/2026Abbott Medical, ZDA
MERLIN PATIENT CARE SYSTEM
28.04.2026P301-93/2026exocad GmbH, DEexoplan
19.05.2026P301-94/2026Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
BeneHeart D1 Automated External Defibrillator
20.05.2026P301-95/2026Life Technologies Corporation, ZDA
Oncomine Dx Express Test Panel
19.05.2026P301-96/2026Drägerwerk AG & Co. KGaA, DEAtlan Family ; 8621100, 8621300, 8621400, 8621500, 8621600 /
Basic UDI-DI: 040486751301035FK19X030W4, 040486751301035FK19ZOOOW9, 040486751301035FK19T010V2
Priloga 1
Priloga 2
20.05.2026P301-97/2026BD Switzerland Sàrl, CH
394501 Petelinček z razcepljenim septumom za dostop Luer BD Q-Syte™ – bel
394600 Petelinček – bel
394601 Petelinček – bel, z barvnimi zatiči
394602 Petelinček – moder
394605 Petelinček – rdeč
394926 Petelinček s podaljševalno cevko – 30 cm
394936 Petelinček s podaljševalno cevko in injekcijskim ventilom – 30 cm
394945 Petelinček s podaljševalno cevko in injekcijskim ventilom – 16 cm
394951 Petelinček s podaljševalno cevko – 54 cm
394961 Petelinček s podaljševalno cevko – 105 cm
394971 Petelinček s podaljševalno cevko in injekcijskim ventilom – 105 cm
394982 Petelinček s podaljševalno cevko – 21 cm (majhna prostornina)
394983 Petelinček s podaljševalno cevko – 35 cm (majhna prostornina)
394995 Petelinček s podaljševalno cevko – 16 cm (bel)
394997 Petelinček s podaljševalno cevko – 16 cm (moder)
25.05.2026P301-99/2026Hamilton Medical AG, CHBreathing circuit set, coaxial for associated ventilators HAMILTON-T1, MR1 and C1
Priloga 1
Priloga 2
Priloga 3
21.05.2026P301-100/2026Immucor GTI Diagnostics, Inc., ZDALIFECODES LifeScreen XP
Priloga 1
Priloga 2
21.05.2026P301-101/2026Datex-Ohmeda, Inc., ZDA
Giraffe OmniBeds – Giraffe OmniBed Carestations
21.05.2026P301-102/2026Deltamedica GmbH, DEBSS Deltamedica 500mL
22.05.2026P301-103/2026Boston Scientific Corporation, ZDACRE™ Wireguided Balloon Dilatation Catheter
25.05.2026P301-104/2026Armstrong Medical Ltd, VB
APL Valve component: Resuscitation Sets (Mapleson Systems)
Paediatric Ayres T‑Piece Systems (Resuscitation Set)
Adult Coaxial Breathing Systems
Positive Expiratory Pressure (PEP) Therapy Devices 
22.05.2026P301-105/2026EPOCAL, CAEpoc BGEM Test Cards
06.05.2026P301-106/2026EntroGen, Inc, ZDA
ctDNA EGFR Mutation Analysis Kit 
28.05.2026P301-107/2026Philips Medical Systems Nederland BV, NL
Allura Xper, Allura Centron, Allura CV20, MD-Eleva
28.05.2026P301-108/2026Löwenstein Medical Innovation GmbH & Co. KG, DE
elisa 300, elisa 500, elisa 600, elisa 800 (VIT)
28.05.2026P301-109/2026COMECER Netherlands B.V., NLIRIS
29.05.2026P301-110/2026ChM sp. z o.o., PLzaklepna vratna plošča
Priloga 1
Priloga 2
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