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10885380181061

Class IMDR 2017/745On the market

Manufacturer: Cardinal Health 200 LLC
Manufacturer SRN: US-MF-000006765
UDI-DI: 10885380181061
Basic UDI-DI: 0630140000000000000010869
Reference: 50000331
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Cardinal Health Ireland Manufacturing Limited
Last updated: 21.09.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

AO cable METEK David

AO Cable

Class IMDR 2017/745On the market

Manufacturer: Opsens Inc.
Manufacturer SRN: CA-MF-000018361
UDI-DI: 07540184013197
Basic UDI-DI: 07540184F201323
Reference: F201319
EMDN: Z12050580
EMDN description: CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Hungary
Authorised representative: Haemonetics Italia s.r.l
Last updated: 21.09.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

AUX cable BNC Male

AUX Cable

Class IMDR 2017/745On the market

Manufacturer: Opsens Inc.
Manufacturer SRN: CA-MF-000018361
UDI-DI: 07540184011018
Basic UDI-DI: 07540184F2011ZU
Reference: F201101
EMDN: Z12050580
EMDN description: CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Hungary
Authorised representative: Haemonetics Italia s.r.l
Last updated: 21.09.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

Direct AO cable Edwards transducer

Class IMDR 2017/745On the market

Manufacturer: Opsens Inc.
Manufacturer SRN: CA-MF-000018361
UDI-DI: 07540184013203
Basic UDI-DI: 07540184F201323
Reference: F201320
EMDN: Z12050580
EMDN description: CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Haemonetics Italia s.r.l
Last updated: 21.09.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

Direct AO cable Utah transducer

Class IMDR 2017/745On the market

Manufacturer: Opsens Inc.
Manufacturer SRN: CA-MF-000018361
UDI-DI: 07540184013227
Basic UDI-DI: 07540184F201323
Reference: F201322
EMDN: Z12050580
EMDN description: CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Haemonetics Italia s.r.l
Last updated: 21.09.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

AUX cable Siemens Sensis

Class IMDR 2017/745On the market

Manufacturer: Opsens Inc.
Manufacturer SRN: CA-MF-000018361
UDI-DI: 07540184011025
Basic UDI-DI: 07540184F2011ZU
Reference: F201102
EMDN: Z12050580
EMDN description: CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Haemonetics Italia s.r.l
Last updated: 21.09.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products View details

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

Manufacturer products View details

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