November

DatumŠtevilka zadeveProizvajalecMedicinski pripomoček
23.10.2025P301-252/2025Rocket Medical Plc, UK
Rocket Seldinger Chest Drain Kit
07.11.2025P301-42/2023Datascope Corp., ZDACardiosave Intra-Aortic Balloon Pumps
Posodobitev obvestila objavljenega februarja 2023
10.11.2025
P301-253/2025Roche Diagnostics GmbH, DE9180 Electrolyte Analyzer
Posodobitev obvestila objavljenega oktobra 2025
13.11.2025P301-96/2025Remote Diagnostic Technologies Ltd., GBTempus Pro
Posodobitev obvestila objavljenega aprila 2025
24.11.2025
P301-50/2025ZOLL Medical Corporation, ZDAPowerheart® G5 AED, Semi-Automatic/ Automatic, G5X
Posodobitev obvestila objavljenega februarja 2025
08.11.2025P301-122/2024Radiometer Medical ApS, DKABL800 FLEX Analyzer
Posodobitev obvestila objavljenega maja 2024
03.11.2025P301-257/2025Becton Dickinson and Company, ZDA
BD BACTEC™ MGIT™ 960 PZA Kit
03.11.2025P301-258/2025Exactech, Inc., ZDAErgo Impactor Handle
04.11.2025P301-259/2025Datascope Corp., ZDA
Cardiosave Intra-Aortic Balloon Pumps
04.11.2025P301-260/2025JJGC Indústria e Comércio de Materiais Dentários S.A., BR
GM Helix Implant, Ti, 4.0X13
04.11.2025P301-261/2025Datascope Corp., ZDACardiosave Intra-Aortic Balloon Pumps
06.11.2025P301-262/2025Elekta Solutions AB, SE
Elekta Synergy, Elekta Infinity, Elekta Harmony, Elekta Harmony Pro, Versa HD, Elekta Evo (EMLA)
07.11.2025P301-263/2025Olympus Medical Systems Corporation, JP
SINGLE USE LIGATING DEVICE POLYLOOP
10.11.2025P301-264/2025Stryker Instruments a division of Stryker Corporation, ZDA -> NICO CORP ZDA
NICO Myriad™ Handpiece | NICO Myriad™ Illumination Pack | NICO BrainPath
03.11.2025P301-265/2025Hill-Rom S.A.S., FRAccella
Obvestilo 1
Obvestilo 2
11.11.2025P301-266/2025Beckman Coulter, ZDA
Access 2 Reaction Vessel
part number 81901
13.11.2025P301-267/2025SCHILLER MEDICAL, FRDEFIGARD Touch-7
13.11.2025P301-268/2025Klaxon Mobility GmbH, ATKLICK
07.11.2025P301-269/2025Datascope Corp., ZDA
Cardiosave Intra-Aortic Balloon Pumps
19.11.2025P301-270/2025Roche Diagnostics GmbH, DE
Elecsys Anti-TSHR

Elecsys Anti-TSHR ( 08496609190) assay for use on cobas e411 and 60x (E1G); IVDR class B, EMDN Code
W0102100302, EMDN text TSH RECEPTOR ANTIBODIES; Basic-UDI-DI: 7613336001229L
Elecsys Anti-TSHR ( 08496633190) assay for use on cobas e801 and e402 (E2G); IVDR class B, EMDN Code
W0102100302, EMDN text TSH RECEPTOR ANTIBODIES; Basic-UDI-DI: 7613336001239N
14.11.2025P301-271/2025BK Medical Aps, DK
Ultrasound system type 2300, 1300, 1202
17.11.2025P301-272/2025Abbott Laboratories, ZDAAlinity ci-series System Control Module (SCM)
Obvestilo 1
Obvestilo 2
20.11.2025P301-273/2025Medtronic, Inc., ZDA
US-MF-000019977
Restore™ Clinician Programmer Application
UDI-DI: 0763000B00000016G
21.11.2025P301-274/2025Medtronic Minimed, ZDA
US-MF-000023100
MMT-7350: CareLink Clinic
Basic UDI-DI: 0763000B00008748K
24.11.2025P301-275/2025Cook Incorporated, ZDA
Flexor® Check-Flo® Introducers and Sets
Rösch-Uchida Transjugular Liver Access Sets
27.11.2025P301-276/2025GE Healthcare GmbH, DE
ViewPoint 6
ViewPoint 6 version 6.15.3, (01)00195278753472(10)ViewPoint6.15.3.0
ViewPoint 6 version 6.15.4, (01)00195278753472(10)ViewPoint6.15.4.0
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