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MPS 3ND Water Hose Kit

5303030

Class IIaMDDOn the market

Manufacturer: Quest Medical, Inc.
Manufacturer SRN: US-MF-000008538
UDI-DI: 20634624530335
Basic UDI-DI: B-20634624530335
Reference: 5303030
EMDN: Z12050201
EMDN description: EXTRA-CORPOREAL CIRCULATION SYSTEMS
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 20:00

Manufacturer products Authorised representative products Authorised representative actors View details

MPS 3 Medical Air Hose Kit

5303010

Class IIaMDDOn the market

Manufacturer: Quest Medical, Inc.
Manufacturer SRN: US-MF-000008538
UDI-DI: 20634624530328
Basic UDI-DI: B-20634624530328
Reference: 5303010
EMDN: Z12050201
EMDN description: EXTRA-CORPOREAL CIRCULATION SYSTEMS
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 20:00

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MPS 3 Console Base Mounting Adapter

5301025

Class IIaMDDOn the market

Manufacturer: Quest Medical, Inc.
Manufacturer SRN: US-MF-000008538
UDI-DI: 20634624530250
Basic UDI-DI: B-20634624530250
Reference: 5301025
EMDN: Z12050201
EMDN description: EXTRA-CORPOREAL CIRCULATION SYSTEMS
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 20:00

Manufacturer products Authorised representative products Authorised representative actors View details

MPS 3 Console Pole Mount Adapter

5301023

Class IIaMDDOn the market

Manufacturer: Quest Medical, Inc.
Manufacturer SRN: US-MF-000008538
UDI-DI: 20634624530236
Basic UDI-DI: B-20634624530236
Reference: 5301023
EMDN: Z12050201
EMDN description: EXTRA-CORPOREAL CIRCULATION SYSTEMS
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 20:00

Manufacturer products Authorised representative products Authorised representative actors View details

MPS 3 Power Cord, Italy

530IT16

Class IIaMDDOn the market

Manufacturer: Quest Medical, Inc.
Manufacturer SRN: US-MF-000008538
UDI-DI: 00634624530249
Basic UDI-DI: B-00634624530249
Reference: 530IT16
EMDN: Z12050201
EMDN description: EXTRA-CORPOREAL CIRCULATION SYSTEMS
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 18:48

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CARTO 3 SYSTEM

CARTO 3 System

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Biosense Webster (Israel) Ltd.
Manufacturer SRN: IL-MF-000017055
UDI-DI: 10846835000870
Basic UDI-DI: 08468350a0002ER
Reference: FG540000
EMDN: Z12059002
EMDN description: CARDIAC MAPPING EQUIPMENT
First on market country: Belgium
Authorised representative: Biosense Webster A Division of Johnson & Johnson Medical NV/SA
Last updated: 21.09.2026 18:40

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MPS 3 ECG Cable

513UECG

Class IIaMDDOn the market

Manufacturer: Quest Medical, Inc.
Manufacturer SRN: US-MF-000008538
UDI-DI: 20634624513123
Basic UDI-DI: B-20634624513123
Reference: 513UECG
EMDN: Z12050201
EMDN description: EXTRA-CORPOREAL CIRCULATION SYSTEMS
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 18:35

Manufacturer products Authorised representative products Authorised representative actors View details

MPS 3 ECG Splitter

513USPT

Class IIaMDDOn the market

Manufacturer: Quest Medical, Inc.
Manufacturer SRN: US-MF-000008538
UDI-DI: 20634624513024
Basic UDI-DI: B-20634624513024
Reference: 513USPT
EMDN: Z12050201
EMDN description: EXTRA-CORPOREAL CIRCULATION SYSTEMS
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 18:35

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MPS 3 ECG Extension Cable

513UEXT

Class IIaMDDOn the market

Manufacturer: Quest Medical, Inc.
Manufacturer SRN: US-MF-000008538
UDI-DI: 20634624513017
Basic UDI-DI: B-20634624513017
Reference: 513UEXT
EMDN: Z12050201
EMDN description: EXTRA-CORPOREAL CIRCULATION SYSTEMS
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 18:35

Manufacturer products Authorised representative products Authorised representative actors View details

NIHON KOHDEN FQW210-3-140

Accu-Plus

Class IMDR 2017/745Not intended for EU marketDirect markingMeasuring functionSingle use

Manufacturer: ISD MEDITECH SDN. BHD.
Manufacturer SRN: MY-MF-000043531
UDI-DI: 09551019818236
Basic UDI-DI: 955101981MCRP-APNG
Reference: ACC-NK210280/200RS
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 12.08.2026 06:42

Manufacturer products Authorised representative products Authorised representative actors View details

SCHILLER 2157-035

Class IMDR 2017/745Not intended for EU marketDirect markingMeasuring functionSingle use

Manufacturer: ISD MEDITECH SDN. BHD.
Manufacturer SRN: MY-MF-000043531
UDI-DI: 09551019818243
Basic UDI-DI: 955101981MCRP-APNG
Reference: ACC-S11494/100RS
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 12.08.2026 06:36

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CardioSignal Inside

Class IIbNot specifiedOn the marketDirect marking

Manufacturer: Precordior Oy
Manufacturer SRN: FI-MF-000014540
UDI-DI: 06430081450083
Basic UDI-DI: 643008145CSAFIB3Y
Reference: Android v. 1.0
EMDN: Z12050892
EMDN description: CARDIAC TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 11.08.2026 22:58

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CardioSignal Inside

Class IIbNot specifiedOn the marketDirect marking

Manufacturer: Precordior Oy
Manufacturer SRN: FI-MF-000014540
UDI-DI: 06430081450076
Basic UDI-DI: 643008145CSAFIB3Y
Reference: iOS v. 1.0
EMDN: Z12050892
EMDN description: CARDIAC TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 11.08.2026 22:58

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CardioSignal

Class IIbNot specifiedOn the marketDirect marking

Manufacturer: Precordior Oy
Manufacturer SRN: FI-MF-000014540
UDI-DI: 06430081450069
Basic UDI-DI: 643008145CSAFIB3Y
Reference: Android v. 3.1
EMDN: Z12050892
EMDN description: CARDIAC TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 11.08.2026 22:58

Manufacturer products View details

CardioSignal

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Precordior Oy
Manufacturer SRN: FI-MF-000014540
UDI-DI: 06430081450052
Basic UDI-DI: 643008145CSAFIB3Y
Reference: iOS v. 3.1
EMDN: Z12050892
EMDN description: CARDIAC TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 11.08.2026 22:58

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μCor Heart Failure and Arrhythmia Management System (HFAMS)

Class IIaMDR 2017/745Not intended for EU marketActive deviceDirect marking

Manufacturer: ZOLL Manufacturing Corporation
Manufacturer SRN: US-MF-000027987
UDI-DI: 00855778005555
Basic UDI-DI: 0855778005K172510WG
Reference: 10A1071
EMDN: Z12050801
EMDN description: COMPLETE CARDIAC TELEMETRY SYSTEMS
First on market country: -
Authorised representative: ZOLL International Holding B.V.
Last updated: 11.08.2026 21:01

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Spectra-H LUX

Class IIaMDDOn the marketActive device

Manufacturer: MEDICAL QUANT LTD
Manufacturer SRN: IL-MF-000025117
UDI-DI: 07290015333061
Basic UDI-DI: B-07290015333061
Reference: 6010040002
EMDN: Z12059008
EMDN description: LASER FLUXIMETRY SYSTEMS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 10.08.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

ICG Electrode

COE0002A

Class IMDR 2017/745On the marketMeasuring functionSingle use

Manufacturer: Shenzhen Med-link Electronics Tech Co., Ltd.
Manufacturer SRN: CN-MF-000011145
UDI-DI: 06944414083621
Basic UDI-DI: 69444140006SQ
Reference: COE0001N
EMDN: Z12050385
EMDN description: ELECTROCARDIOGRAPHS - CONSUMABLES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.08.2026 07:03

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05060434424839

Quantum Centrifugal Emergency Hand Crank High Pressure

Class IMDR 2017/745On the market

Manufacturer: Spectrum Medical Ltd
Manufacturer SRN: GB-MF-000033594
UDI-DI: 05060434424839
Basic UDI-DI: 506043442QCDHC2L
Reference: 52-000149-00
EMDN: Z12050280
EMDN description: EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Italy
Authorised representative: Spectrum Medical S.r.l.
Last updated: 08.08.2026 11:29

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Cardiac, 10-Lead, IEC, Basic Monitoring Kit

QMAPP Consumables

Class IMDR 2017/745On the market

Manufacturer: Fysicon B.V.
Manufacturer SRN: NL-MF-000002694
UDI-DI: 08720938410383
Basic UDI-DI: 8719689142QMAPPCONSKJ
Reference: 01076150
EMDN: Z12050785
EMDN description: INSTRUMENTS FOR CARDIOLOGICAL POLYGRAPHY - CONSUMABLES
First on market country: Netherlands
Authorised representative: -
Last updated: 07.08.2026 02:54

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