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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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KENZ SUZUKEN R183-52Z-D

ALPHA-PLUS

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

Manufacturer: ISD MEDITECH SDN. BHD.
Manufacturer SRN: MY-MF-000043531
UDI-DI: 09551026271697
Basic UDI-DI: 955102627MCRPAPFF
Reference: APP-K183280-200RS
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 00:19

Manufacturer products Authorised representative products Authorised representative actors View details

BIOCARE ECG ROLL (210MM X 30M)

SKYMED

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

Manufacturer: ISD MEDITECH SDN. BHD.
Manufacturer SRN: MY-MF-000043531
UDI-DI: 09551026270034
Basic UDI-DI: 955102627MCRP-SMMG
Reference: SK-21030-16R3
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 00:18

Manufacturer products Authorised representative products Authorised representative actors View details

SCHILLER 2157-055

ALPHA-PLUS

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

Manufacturer: ISD MEDITECH SDN. BHD.
Manufacturer SRN: MY-MF-000043531
UDI-DI: 09551019818519
Basic UDI-DI: 955101981MCRPAPH3
Reference: APP-S114150-60RS
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 00:18

Manufacturer products Authorised representative products Authorised representative actors View details

NIHON KOHDEN FQW110-2-140

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: 09551019810780
Basic UDI-DI: 955101981MCRP-APNG
Reference: ACC-NK110140/143S
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

ultrasound paper 110mmx20m standard, Type 1),Alpha-Plus

ALPHA-PLUS

Class IMDR 2017/745Not intended for EU marketDirect markingSingle use

Manufacturer: ISD MEDITECH SDN. BHD.
Manufacturer SRN: MY-MF-000043531
UDI-DI: 09551019810711
Basic UDI-DI: 955101981USPAPLQ
Reference: APP110S
EMDN: Z11040185
EMDN description: ULTRASOUND SCANNERS - CONSUMABLES
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

Ultrasound Paper 110mm x 20m (Standard, Type I) ACCU-PLUS

Accu-Plus

Class IMDR 2017/745Not intended for EU marketDirect markingSingle use

Manufacturer: ISD MEDITECH SDN. BHD.
Manufacturer SRN: MY-MF-000043531
UDI-DI: 09551019810650
Basic UDI-DI: 955101981USP-APL3
Reference: ACC-110S
EMDN: Z11040185
EMDN description: ULTRASOUND SCANNERS - CONSUMABLES
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

NIHON KOHDEN FQW110-2-140

SKYMED

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

Manufacturer: ISD MEDITECH SDN. BHD.
Manufacturer SRN: MY-MF-000043531
UDI-DI: 09551019810247
Basic UDI-DI: 955101981MCRP-SMPY
Reference: SK-NK110140-143S
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

Ultrasound Paper 110mm x 20m (Standard, Type I) Skymed

SKYMED

Class IMDR 2017/745Not intended for EU marketDirect markingSingle use

Manufacturer: ISD MEDITECH SDN. BHD.
Manufacturer SRN: MY-MF-000043531
UDI-DI: 09551019810186
Basic UDI-DI: 955101981USP-SMMK
Reference: SM110S
EMDN: Z11040185
EMDN description: ULTRASOUND SCANNERS - CONSUMABLES
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

Sky GEL ECG Gel 260E

Sky GEL

Class IMDR 2017/745Not intended for EU marketDirect markingSingle use

Manufacturer: ISD MEDITECH SDN. BHD.
Manufacturer SRN: MY-MF-000043531
UDI-DI: 09551019810070
Basic UDI-DI: 955101981ECG-GELB2
Reference: SKYGEL260E
EMDN: C020599
EMDN description: CARDIAC DIAGNOSTIC DEVICES - OTHER
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

Sky GEL Ultrasound Transmission Medical Gel

Sky GEL

Class IMDR 2017/745Not intended for EU marketDirect markingSingle use

Manufacturer: ISD MEDITECH SDN. BHD.
Manufacturer SRN: MY-MF-000043531
UDI-DI: 09551019810032
Basic UDI-DI: 955101981US-GELGN
Reference: SKYGEL260B
EMDN: Z11040185
EMDN description: ULTRASOUND SCANNERS - CONSUMABLES
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

NIHON KOHDEN FV215-30

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

Manufacturer: ISD MEDITECH SDN. BHD.
Manufacturer SRN: MY-MF-000043531
UDI-DI: 09551026273585
Basic UDI-DI: 955102627MCRPAPFF
Reference: APP-NK215300-1000Y
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 22.06.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

NIHON KOHDEN FV245-30

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

Manufacturer: ISD MEDITECH SDN. BHD.
Manufacturer SRN: MY-MF-000043531
UDI-DI: 09551026273592
Basic UDI-DI: 955102627MCRPAPFF
Reference: APP-NK245300-1000Y
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 22.06.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

Sky Gel ECG Gel 5000E

Class IMDR 2017/745Not intended for EU marketDirect markingSingle use

Manufacturer: ISD MEDITECH SDN. BHD.
Manufacturer SRN: MY-MF-000043531
UDI-DI: 09551019810087
Basic UDI-DI: 955101981ECG-GELB2
Reference: SKYGEL5000E
EMDN: C020599
EMDN description: CARDIAC DIAGNOSTIC DEVICES - OTHER
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 21.06.2026 17:14

Manufacturer products Authorised representative products Authorised representative actors View details

HELLIGE MARQUETTE 2261 6611/2261 6605

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

Manufacturer: ISD MEDITECH SDN. BHD.
Manufacturer SRN: MY-MF-000043531
UDI-DI: 09551019810254
Basic UDI-DI: 955101981MCRP-SMPY
Reference: SK-HM210295-150RS
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 21.06.2026 17:14

Manufacturer products Authorised representative products Authorised representative actors View details

HEWLETT PACKARD / PHILIPS M1911A

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

Manufacturer: ISD MEDITECH SDN. BHD.
Manufacturer SRN: MY-MF-000043531
UDI-DI: 09551019810261
Basic UDI-DI: 955101981MCRP-SMPY
Reference: SK-P150100-150GNS
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 21.06.2026 17:14

Manufacturer products Authorised representative products Authorised representative actors View details

COROMETRICS AAO 4305/CAO 4305

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

Manufacturer: ISD MEDITECH SDN. BHD.
Manufacturer SRN: MY-MF-000043531
UDI-DI: 09551019810278
Basic UDI-DI: 955101981MCRP-SMPY
Reference: SK-CO15290-150R
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 21.06.2026 17:14

Manufacturer products Authorised representative products Authorised representative actors View details

HEWLETT PACKARD / PHILIPS M1709A/M2483A/M3708A

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

Manufacturer: ISD MEDITECH SDN. BHD.
Manufacturer SRN: MY-MF-000043531
UDI-DI: 09551019810285
Basic UDI-DI: 955101981MCRP-SMPY
Reference: SK-P210300-200R
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 21.06.2026 17:14

Manufacturer products Authorised representative products Authorised representative actors View details

FUKUDA DENSHI OP-222TE

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

Manufacturer: ISD MEDITECH SDN. BHD.
Manufacturer SRN: MY-MF-000043531
UDI-DI: 09551019810292
Basic UDI-DI: 955101981MCRP-SMPY
Reference: SK-FD110140-142RS
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 21.06.2026 17:14

Manufacturer products Authorised representative products Authorised representative actors View details

NIHON KOHDEN FQW210-3-140

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

Manufacturer: ISD MEDITECH SDN. BHD.
Manufacturer SRN: MY-MF-000043531
UDI-DI: 09551019810308
Basic UDI-DI: 955101981MCRP-SMPY
Reference: SK-NK210140-200S
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 21.06.2026 17:14

Manufacturer products Authorised representative products Authorised representative actors View details

NIHON KOHDEN PA9100Z

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

Manufacturer: ISD MEDITECH SDN. BHD.
Manufacturer SRN: MY-MF-000043531
UDI-DI: 09551019810315
Basic UDI-DI: 955101981MCRP-SMPY
Reference: SK-NK210140-142RS
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 21.06.2026 17:14

Manufacturer products Authorised representative products Authorised representative actors View details