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ECG247

353 010

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Appsens AS
Manufacturer SRN: NO-MF-000013438
UDI-DI: 07090052220023
Basic UDI-DI: 709005222ECG247SENSORZ2
Reference: 1
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Norway
Authorised representative: -
Last updated: 03.07.2026 01:15

Manufacturer products View details

ECG Recorder

E-10、E-20、E-30

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

Manufacturer: Qingdao Weheal Technology co., Ltd
Manufacturer SRN: CN-MF-000039585
UDI-DI: 06976389830108
Basic UDI-DI: 697638983E00UV
Reference: None
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 21:07

Manufacturer products Authorised representative products Authorised representative actors View details

ECG Recorder

Y-21,Y-22,Y-11,Y-12,Y-31,Y-32

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

Manufacturer: Qingdao Weheal Technology co., Ltd
Manufacturer SRN: CN-MF-000039585
UDI-DI: 06976389830023
Basic UDI-DI: 697638983Y00XZ
Reference: None
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 21:07

Manufacturer products Authorised representative products Authorised representative actors View details

06973075231201

HP01

Class IMDR 2017/745On the market

Manufacturer: Wenzhou Shengkai Technology Industry Co., Ltd.
Manufacturer SRN: CN-MF-000021411
UDI-DI: 06973075231201
Basic UDI-DI: 697307523HolterPocketSC
Reference: HP01
EMDN: Z12050485
EMDN description: HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 13:34

Manufacturer products Authorised representative products Authorised representative actors View details

Wearable DECG Recorder

TER011、TER012、EP-3

Class IIaMDR 2017/745On the market

Manufacturer: THOTH (Suzhou) Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000034906
UDI-DI: 06971438610014
Basic UDI-DI: 697143861000001PA
Reference: TER011、TER012、EP-3
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Germany
Authorised representative: Everbiz GmbH
Last updated: 02.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

Wearable ECG Sensor

LES-1、LES-2、LES-3、LES-X

Class IMDR 2017/745On the market

Manufacturer: THOTH (Suzhou) Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000034906
UDI-DI: 06971438610007
Basic UDI-DI: 697143861000004PG
Reference: LES-1、LES-2、LES-3、LES-X
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Germany
Authorised representative: Everbiz GmbH
Last updated: 02.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

Ambulatory Blood Pressure Recorders and Associated Software

iH-B

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
Manufacturer SRN: CN-MF-000005653
UDI-DI: 06937683471527
Basic UDI-DI: 69376834iHBB5
Reference: 90310911
EMDN: Z12050404
EMDN description: BLOOD PRESSURE HOLTER RECORDERS
First on market country: Türkiye
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:14

Manufacturer products Authorised representative products Authorised representative actors View details

Ambulatory Electrocardiographs

iH-12PLUS，iH-3PLUS

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
Manufacturer SRN: CN-MF-000005653
UDI-DI: 06937683471114
Basic UDI-DI: 69376834iHLQ
Reference: 90310181-01
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:14

Manufacturer products Authorised representative products Authorised representative actors View details

LEPU MEDICAL

XAB-M3AG、 XAB-M12AL、 iHolter-3、 iHolter-12、 LeHolter-3、 LeHolter-12

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Viatom Technology Co., Ltd.
Manufacturer SRN: CN-MF-000012182
UDI-DI: 06934440102670
Basic UDI-DI: 69344401iHolter-12LM
Reference: XAB-M12AL
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 09:58

Manufacturer products Authorised representative products Authorised representative actors View details

LEPU

M5，M12，Lepod，Lepod Pro，LMT-5，LMT-12

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Viatom Technology Co., Ltd.
Manufacturer SRN: CN-MF-000012182
UDI-DI: 06934440101963
Basic UDI-DI: 69344401M12WA
Reference: M12
EMDN: Z12050402
EMDN description: MULTI–PARAMETER CARDIOVASCULAR HOLTER RECORDERS (ECG, NIPB, ETC.)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 09:58

Manufacturer products Authorised representative products Authorised representative actors View details

Wellue

ER1-LW，ER1-LB

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Viatom Technology Co., Ltd.
Manufacturer SRN: CN-MF-000012182
UDI-DI: 06934440101918
Basic UDI-DI: 69344401ER1-LWER
Reference: ER1-LW
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 09:58

Manufacturer products Authorised representative products Authorised representative actors View details

Comarch Holter

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Comarch Telemedicine Sp. z o.o.
Manufacturer SRN: PL-MF-000049884
UDI-DI: 05905331580137
Basic UDI-DI: 590533158HOLTER.1185V
Reference: 05905331580137
EMDN: Z12050492
EMDN description: HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - MEDICAL DEVICE SOFTWARE
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 06:09

Manufacturer products View details

Comarch ECGViewer 2.0

ECG.Viewer.P2

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Comarch Telemedicine Sp. z o.o.
Manufacturer SRN: PL-MF-000049884
UDI-DI: 05905331580038
Basic UDI-DI: 590533158ECGVIEW2.12L5
Reference: 05905331580038
EMDN: Z12050492
EMDN description: HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - MEDICAL DEVICE SOFTWARE
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 06:09

Manufacturer products View details

Comarch CardioViewer

CARDIOVIEWER.P2

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Comarch Telemedicine Sp. z o.o.
Manufacturer SRN: PL-MF-000049884
UDI-DI: 05905331580021
Basic UDI-DI: 590533158CVVIEWER2.129X
Reference: 05905331580021
EMDN: Z12050492
EMDN description: HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - MEDICAL DEVICE SOFTWARE
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 06:09

Manufacturer products View details

PocketECG IV

P4TR-CE-ADS

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Medicalgorithmics S.A.
Manufacturer SRN: PL-MF-000011413
UDI-DI: 05903021560247
Basic UDI-DI: 590302156PECGT-IVMG
Reference: 05903021560247
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 05:30

Manufacturer products View details

dpv-ritmo III

ECG Holter Recorder

Class IIaMDR 2017/745On the marketActive device

Manufacturer: livetec Ingenieurbüro GmbH
Manufacturer SRN: DE-MF-000005598
UDI-DI: 04260585220668
Basic UDI-DI: 426058522ECG-RecorderB8
Reference: 106881
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 22:49

Manufacturer products View details

PADSY Holter 4.6

PADSY Holter

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Medset Medizintechnik GmbH
Manufacturer SRN: DE-MF-000016442
UDI-DI: 04250403710228
Basic UDI-DI: 42504037AAG118000-01BY
Reference: AAG118102
EMDN: Z12050492
EMDN description: HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 21:30

Manufacturer products View details

Somno-Art Software

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: PPRS
Manufacturer SRN: FR-MF-000013227
UDI-DI: 37700248000124
Basic UDI-DI: 3770024800SASoftwareX9
Reference: 3770024800SASoftwareX9
EMDN: Z12050492
EMDN description: HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:10

Manufacturer products View details

Brassard Diasys 3+ Standard (avec microphone)

Accessories Cuff systems

Class IMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: NOVACOR
Manufacturer SRN: FR-MF-000017735
UDI-DI: 03700814300309
Basic UDI-DI: 37008143BRA0001WV
Reference: ACC-0210-00
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Belgium
Authorised representative: -
Last updated: 01.07.2026 14:32

Manufacturer products View details

Câble ECG 5 brins Standard Gris (CHB)

Accessories Cables

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: NOVACOR
Manufacturer SRN: FR-MF-000017735
UDI-DI: 03700814300125
Basic UDI-DI: 37008143CAB0001QU
Reference: ACC-0103-04
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Austria
Authorised representative: -
Last updated: 01.07.2026 14:32

Manufacturer products View details