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Khelix Duodecapolar Variable Loop Steerable Electrophysiology Catheter

Diagnostic Loop Steerable Electrophysiology Catheter

Class IIIMDDOn the marketSingle useSterile

Manufacturer: CathRx Ltd
Manufacturer SRN: AU-MF-000002757
UDI-DI: 09351351000111
Basic UDI-DI: B-09351351000111
Reference: SC2-B2515U-20P7262
EMDN: C02010403
EMDN description: ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, ADJUSTABLE
First on market country: Germany
Authorised representative: Advena Limited
Last updated: 17.07.2026 23:55

Manufacturer products Authorised representative products Authorised representative actors View details

Khelix Decapolar Fixed Loop Steerable Electrophysiology Catheter

Diagnostic Loop Steerable Electrophysiology Catheter

Class IIIMDDOn the marketSingle useSterile

Manufacturer: CathRx Ltd
Manufacturer SRN: AU-MF-000002757
UDI-DI: 09351351000081
Basic UDI-DI: B-09351351000081
Reference: SC1-B20U-10P7666
EMDN: C02010403
EMDN description: ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, ADJUSTABLE
First on market country: Germany
Authorised representative: Advena Limited
Last updated: 17.07.2026 23:55

Manufacturer products Authorised representative products Authorised representative actors View details

Khelix Decapolar Fixed Loop Steerable Electrophysiology Catheter

Diagnostic Loop Steerable Electrophysiology Catheter

Class IIIMDDOn the marketSingle useSterile

Manufacturer: CathRx Ltd
Manufacturer SRN: AU-MF-000002757
UDI-DI: 09351351000074
Basic UDI-DI: B-09351351000074
Reference: SC1-B15U-10P7555
EMDN: C02010403
EMDN description: ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, ADJUSTABLE
First on market country: Germany
Authorised representative: Advena Limited
Last updated: 17.07.2026 23:55

Manufacturer products Authorised representative products Authorised representative actors View details

ePatch

Class INot specifiedNo longer on the marketSingle use

Manufacturer: Braemar Manufacturing, LLC
Manufacturer SRN: US-MF-000036101
UDI-DI: B146EPE21
Basic UDI-DI: ++B146PatchElectrodeHC
Reference: 02‐01507
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: -
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 17.07.2026 04:20

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Khelix Diagnostic Extension Cable 20pin

Khelix Diagnostic Extension Cable

Class IMDDOn the marketReusableSterile

Manufacturer: CathRx Ltd
Manufacturer SRN: AU-MF-000002757
UDI-DI: 09351351000135
Basic UDI-DI: B-09351351000135
Reference: X-D20
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Germany
Authorised representative: Advena Limited
Last updated: 17.07.2026 01:10

Manufacturer products Authorised representative products Authorised representative actors View details

Khelix Diagnostic Extension Cable 10pin

Khelix Diagnostic Extension Cable

Class IMDDOn the marketReusableSterile

Manufacturer: CathRx Ltd
Manufacturer SRN: AU-MF-000002757
UDI-DI: 09351351000128
Basic UDI-DI: B-09351351000128
Reference: X-D10
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Germany
Authorised representative: Advena Limited
Last updated: 17.07.2026 01:10

Manufacturer products Authorised representative products Authorised representative actors View details

STABLE BASE

ECG Electrode

Class IMDR 2017/745Not intended for EU marketSingle use

Manufacturer: Leonhard Lang GmbH
Manufacturer SRN: AT-MF-000000426
UDI-DI: 10861779000274
Basic UDI-DI: 9005531ECGElectrodesCM
Reference: SBW601
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: -
Authorised representative: -
Last updated: 16.07.2026 12:56

Manufacturer products View details

ECG Electrodes and accessories

ECG electrodes and accessories

Class IMDR 2017/745On the market

Manufacturer: Spes Medica S.p.A.
Manufacturer SRN: IT-MF-000008858
UDI-DI: 18054655024156
Basic UDI-DI: 8054655000019YB
Reference: LEAD252622
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 12:04

Manufacturer products View details

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

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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

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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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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