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SZcaremed

EK10U-NK2-BI

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Shenzhen Caremed Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000010579
UDI-DI: 06931973405735
Basic UDI-DI: 69707585ECG01QK
Reference: ED3D-60－1
EMDN: C020599
EMDN description: CARDIAC DIAGNOSTIC DEVICES - OTHER
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

Patch ECG Electrode

Class IMDR 2017/745On the marketSingle use

Manufacturer: Suzhou Beneware Medical Equipment Co.,Ltd.
Manufacturer SRN: CN-MF-000015853
UDI-DI: 06958066424060
Basic UDI-DI: 69580664EL1602JG
Reference: EL-05B-EN
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:51

Manufacturer products Authorised representative products Authorised representative actors View details

Patch ECG Electrode

Class IMDR 2017/745On the marketSingle use

Manufacturer: Suzhou Beneware Medical Equipment Co.,Ltd.
Manufacturer SRN: CN-MF-000015853
UDI-DI: 06958066424046
Basic UDI-DI: 69580664EL1601JE
Reference: EL-03A-EN
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:51

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Rotatable connector

5944RL

Class IMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Shenzhen Launch Electrical Co.,Ltd
Manufacturer SRN: CN-MF-000028780
UDI-DI: 06947437902535
Basic UDI-DI: 69474379CompassBP
Reference: 5944RL
EMDN: C020280
EMDN description: TEMPORARY CARDIAC ELECTRICAL STIMULATION DEVICES - ACCESSORIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:43

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Disposable Defibrillation Electrodes

DE0001A

Class IMDR 2017/745On the marketActive deviceMeasuring functionSingle use

Manufacturer: Shenzhen Med-link Electronics Tech Co., Ltd.
Manufacturer SRN: CN-MF-000011145
UDI-DI: 06944414051323
Basic UDI-DI: 69444140015SR
Reference: DE0002A
EMDN: C020401
EMDN description: EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:40

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ECG Electrode

Class IMDR 2017/745On the marketSingle use

Manufacturer: Shenzhen Med-link Electronics Tech Co., Ltd.
Manufacturer SRN: CN-MF-000011145
UDI-DI: 06944414006842
Basic UDI-DI: 69444140005SN
Reference: V0014-C0405A
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Disposable ECG electrode

AMD-DA

Class IMDR 2017/745On the marketReprocessedSingle use

Manufacturer: Shenzhen Amydi-med Electrics Tech Co.,Ltd
Manufacturer SRN: CN-MF-000013201
UDI-DI: 06931377244800
Basic UDI-DI: 69313772817UZ
Reference: AMD-DA-AF0001-X
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Denmark
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 10:29

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Elektrody EKG

EK-S

Class IMDR 2017/745On the marketSingle use

Manufacturer: SORIMEX sp. z o.o.
Manufacturer SRN: PL-MF-000020958
UDI-DI: 05903002217573
Basic UDI-DI: 5903002221125B
Reference: EK-S 60 P
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Poland
Authorised representative: -
Last updated: 16.07.2026 10:10

Manufacturer products View details

przewód dołączeniowy

leadwires

Class IMDR 2017/745On the market

Manufacturer: SORIMEX sp. z o.o.
Manufacturer SRN: PL-MF-000020958
UDI-DI: 05903002213469
Basic UDI-DI: 59030022211057
Reference: PD-H-2/L-20-32
EMDN: C020599
EMDN description: CARDIAC DIAGNOSTIC DEVICES - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 16.07.2026 10:10

Manufacturer products View details

Adapterkabel MAC 2000

Adapter zum GE Cardiac CC14 Modul

Class IMDR 2017/745On the market

Manufacturer: mbnet Engineering GmbH
Manufacturer SRN: DE-MF-000007410
UDI-DI: 04260718722045
Basic UDI-DI: 426071872AdapterforGELZ
Reference: 350566
EMDN: C020599
EMDN description: CARDIAC DIAGNOSTIC DEVICES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 09:20

Manufacturer products View details

livePatch

Single Patch Electrode

Class IMDR 2017/745On the marketSingle use

Manufacturer: livetec Ingenieurbüro GmbH
Manufacturer SRN: DE-MF-000005598
UDI-DI: 04260585220156
Basic UDI-DI: 426058522ECG-Patch6V
Reference: 105898
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 09:19

Manufacturer products View details

Lecstrip

various

Class IMDR 2017/745On the marketSingle use

Manufacturer: ASFALIS
Manufacturer SRN: FR-MF-000003046
UDI-DI: 03760286540016
Basic UDI-DI: 3760286540235035DP
Reference: A1-50R2-1
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 08:04

Manufacturer products View details

Vital Signs™ Suction Electrode for KISS™ System

Suction Electrode for KISS System

Class IMDR 2017/745On the market

Manufacturer: AirLife Finland Oy
Manufacturer SRN: FI-MF-000001482
UDI-DI: 10889483578612
Basic UDI-DI: 088948320041bDCAR8HZ
Reference: 21732801
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Finland
Authorised representative: -
Last updated: 16.07.2026 07:55

Manufacturer products View details

Vital Signs™ Reusable Electrode, Suction, Thorax

Suction Bulb Electrode

Class IMDR 2017/745On the market

Manufacturer: AirLife Finland Oy
Manufacturer SRN: FI-MF-000001482
UDI-DI: 10889483578582
Basic UDI-DI: 088948320041bDCAR10WW
Reference: 21714401
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Finland
Authorised representative: -
Last updated: 16.07.2026 07:55

Manufacturer products View details

WAVE1 Activation Materials

Class IIbNot specifiedOn the marketDirect marking

Manufacturer: CardioFocus
Manufacturer SRN: US-MF-000008457
UDI-DI: 00860014679650
Basic UDI-DI: 08600146796GTI-00036QE
Reference: GTI-00036
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION DEVICES - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:55

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AcQMap 3D Imaging and Mapping Catheter

900009

Class IIIMDR 2017/745On the marketSingle useSterile

Manufacturer: Acutus Medical, Inc.
Manufacturer SRN: US-MF-000019413
UDI-DI: 00857042007401
Basic UDI-DI: 0857042007ACQMAPCATHNW
Reference: 900009
EMDN: C020105
EMDN description: NON-CONVENTIONAL MAPPING (CONTACT AND NON-CONTACT) THREE-DIMENSIONAL DIAGNOSTIC CATHETERS
First on market country: Germany
Safety summary (SSCP/SSP): QR-475 · Rev. 01
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 06:41

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

LifeVest Wearable Defibrillator, Model 4000

LifeVest Wearable Defibrillator - Garment

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: ZOLL Manufacturing Corporation
Manufacturer SRN: US-MF-000027987
UDI-DI: 00855778005111
Basic UDI-DI: 0855778005P010030GYK
Reference: 10A1004
EMDN: C020480
EMDN description: CARDIOVERSION AND EXTERNAL DEFIBRILLATION DEVICES - ACCESSORIES
First on market country: France
Authorised representative: ZOLL International Holding B.V.
Last updated: 16.07.2026 06:40

Manufacturer products Authorised representative products Authorised representative actors View details

LifeVest Wearable Defibrillator, Model 4000

LifeVest Wearable Defibrillator - Battery Pack

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: ZOLL Manufacturing Corporation
Manufacturer SRN: US-MF-000027987
UDI-DI: 00855778005036
Basic UDI-DI: 0855778005P010030BP7X
Reference: 10A0989
EMDN: C020480
EMDN description: CARDIOVERSION AND EXTERNAL DEFIBRILLATION DEVICES - ACCESSORIES
First on market country: France
Authorised representative: ZOLL International Holding B.V.
Last updated: 16.07.2026 06:40

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LifeVest Wearable Defibrillator, Model 4000

LifeVest Wearable Defibrillator - Battery Charger

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: ZOLL Manufacturing Corporation
Manufacturer SRN: US-MF-000027987
UDI-DI: 00855778005029
Basic UDI-DI: 0855778005P010030BC75
Reference: 10A0985
EMDN: C020480
EMDN description: CARDIOVERSION AND EXTERNAL DEFIBRILLATION DEVICES - ACCESSORIES
First on market country: France
Authorised representative: ZOLL International Holding B.V.
Last updated: 16.07.2026 06:40

Manufacturer products Authorised representative products Authorised representative actors View details

LifeVest Wearable Defibrillator, Model 4000

LifeVest Wearable Defibrillator - Electrode Belt

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: ZOLL Manufacturing Corporation
Manufacturer SRN: US-MF-000027987
UDI-DI: 00855778005012
Basic UDI-DI: 0855778005P010030EB7C
Reference: 10A0987
EMDN: C020480
EMDN description: CARDIOVERSION AND EXTERNAL DEFIBRILLATION DEVICES - ACCESSORIES
First on market country: France
Authorised representative: ZOLL International Holding B.V.
Last updated: 16.07.2026 06:40

Manufacturer products Authorised representative products Authorised representative actors View details