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EUDAMED Device Search

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

Last updated

01.08.2026 01:12

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257 device results listed.

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Dynamic ECG Systems

TLC5000, TLC6000

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Contec Medical Systems Co., Ltd.
Manufacturer SRN: CN-MF-000007715
UDI-DI: 06945040100294
Basic UDI-DI: 69450401TLC6000GX
Reference: TLC5000
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Poland
Authorised representative: Prolinx GmbH
Last updated: 31.07.2026 20:02

Manufacturer products Authorised representative products Authorised representative actors View details

Bittium MINI UL

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Bittium Biosignals Oy
Manufacturer SRN: FI-MF-000013983
UDI-DI: 06430035220885
Basic UDI-DI: 643003522Cardiac3Z
Reference: S0000018246
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:51

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EC-2H System

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.
Manufacturer SRN: HU-MF-000002846
UDI-DI: 05999883490006
Basic UDI-DI: 5999883490HOLTERSR9
Reference: EC-2H Recorder
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:47

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Rejestrator holterowski EKG

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: SynexCare sp. z o.o.
Manufacturer SRN: PL-MF-000038028
UDI-DI: 05905471789018
Basic UDI-DI: 590547178901002QB
Reference: 1002100000
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 14:06

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C3+ Holter Monitor

C3+ Holter Monitor

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Cortrium ApS
Manufacturer SRN: DK-MF-000007827
UDI-DI: 05745000379002
Basic UDI-DI: 5745000379HolterMonitorVN
Reference: 50002
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:39

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Multichannel Electrocardiograph

PHS-U10

Class IIaMDR 2017/745On the market

Manufacturer: PhysioSign Hong Kong Medical Limited
Manufacturer SRN: CN-MF-000041466
UDI-DI: 04897139610011
Basic UDI-DI: 489713961001L4
Reference: PHS-U10
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Germany
Authorised representative: Everbiz GmbH
Last updated: 31.07.2026 07:18

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Rooti Rx System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Rooti Labs Limited.
Manufacturer SRN: TW-MF-000004839
UDI-DI: 04719873370092
Basic UDI-DI: 471987337RootiRxDJ
Reference: RXAP02, RXAP03, RXMD01, RXMD02, ASCD01
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 06:37

Manufacturer products Authorised representative products Authorised representative actors View details

ECG Holter Recorder

Class IIaMDR 2017/745On the marketActive device

Manufacturer: livetec Ingenieurbüro GmbH
Manufacturer SRN: DE-MF-000005598
UDI-DI: 04260585221818
Basic UDI-DI: 426058522ECG-RecorderB8
Reference: 107158
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:28

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ECG Holter Recorder

Class IIaMDR 2017/745On the marketActive device

Manufacturer: livetec Ingenieurbüro GmbH
Manufacturer SRN: DE-MF-000005598
UDI-DI: 04260585220781
Basic UDI-DI: 426058522ECG-RecorderB8
Reference: 106877
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:21

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kECG-3 (Kardiobeat.ai)

ECG Holter Recorder

Class IIaMDR 2017/745On the marketActive device

Manufacturer: livetec Ingenieurbüro GmbH
Manufacturer SRN: DE-MF-000005598
UDI-DI: 04260585220644
Basic UDI-DI: 426058522ECG-RecorderB8
Reference: 106895
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:11

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NR Series Ambulatory-ECG

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Norav Medical GmbH
Manufacturer SRN: DE-MF-000006715
UDI-DI: 04260498565061
Basic UDI-DI: 426049856DE55252NMAMBTG
Reference: NR302-D-00E-04
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:02

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Ambulatory Electrocardiograph

Model 1303

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Vasomedical Inc.
Manufacturer SRN: US-MF-000030121
UDI-DI: 00817980020191
Basic UDI-DI: 0817980021303YC
Reference: 04.13.03.0001
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Germany
Authorised representative: phoenix Medtech GmbH
Last updated: 30.07.2026 20:00

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Model 1306

Class IIaMDR 2017/745On the market

Manufacturer: Vasomedical Inc.
Manufacturer SRN: US-MF-000030121
UDI-DI: 00817980020184
Basic UDI-DI: 0817980021306YJ
Reference: 04.13.06.0001
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Germany
Authorised representative: phoenix Medtech GmbH
Last updated: 30.07.2026 20:00

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HeartX Recorder

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GETEMED Medizin- und Informationstechnik AG
Manufacturer SRN: DE-MF-000012384
UDI-DI: 04250903203039
Basic UDI-DI: 0425090320274NK
Reference: 86100; 86100-IEM
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:34

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ePatch 2.5 ECG Recorder

ePatch 2.5

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Braemar Manufacturing, LLC
Manufacturer SRN: US-MF-000036101
UDI-DI: B146EP2520
Basic UDI-DI: B-B146EP2520
Reference: 02-02046
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Netherlands
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 30.07.2026 18:08

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ePatch 2.0 Sensor

ePatch 2.0

Class IIaMDDNo longer on the marketActive deviceMeasuring function

Manufacturer: Braemar Manufacturing, LLC
Manufacturer SRN: US-MF-000036101
UDI-DI: B146EP2020
Basic UDI-DI: B-B146EP2020
Reference: 02-01650
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Netherlands
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 30.07.2026 18:08

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EC-12H Holter Recorder

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.
Manufacturer SRN: HU-MF-000002846
UDI-DI: D-SET12HLC05B3
Basic UDI-DI: B-SET12HLC05B3
Reference: SET-12HLC-05 B
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Hungary
Authorised representative: -
Last updated: 23.07.2026 20:00

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EC-3H Holter Recorder

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.
Manufacturer SRN: HU-MF-000002846
UDI-DI: D-SET03HLC05AX
Basic UDI-DI: B-SET03HLC05AX
Reference: SET-03HLC-05 B
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Hungary
Authorised representative: -
Last updated: 23.07.2026 20:00

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EC-2H Holter Recorder

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.
Manufacturer SRN: HU-MF-000002846
UDI-DI: D-SET02HLC05AJ
Basic UDI-DI: B-SET02HLC05AJ
Reference: SET-02HLC-05 B
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Hungary
Authorised representative: -
Last updated: 23.07.2026 20:00

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EC-12H System

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.
Manufacturer SRN: HU-MF-000002846
UDI-DI: D-SYS12HLC05QU
Basic UDI-DI: B-SYS12HLC05QU
Reference: SYS-12HLC-05
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Hungary
Authorised representative: -
Last updated: 23.07.2026 19:57

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