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00190199649286

2.X

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Apple Inc.
Manufacturer SRN: US-MF-000013709
UDI-DI: 00190199649286
Basic UDI-DI: 0190199ECGApp2QP
Reference: ECG app 2.X
EMDN: Z12050382
EMDN description: ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Apple Distribution International Limited
Last updated: 15.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

00190198909534

1.X

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Apple Inc.
Manufacturer SRN: US-MF-000013709
UDI-DI: 00190198909534
Basic UDI-DI: 0190198ECGAppMY
Reference: ECG app 1.X
EMDN: Z12050382
EMDN description: ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Apple Distribution International Limited
Last updated: 15.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

CardioPad Lite

CPL-T1

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Aizoi s.r.l.
Manufacturer SRN: IT-MF-000026605
UDI-DI: G419CPLT10
Basic UDI-DI: ++G419CARDIOPAD9U
Reference: CPL-T1
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Italy
Authorised representative: -
Last updated: 15.07.2026 21:04

Manufacturer products View details

D-Heart

Class IIaMDR 2017/745On the marketDirect markingMeasuring function

Manufacturer: Strena Medical Srl Società Benefit
Manufacturer SRN: IT-MF-000021080
UDI-DI: +G243ECG000DHR200
Basic UDI-DI: ++G243DHEARTECG4L
Reference: ECG000-DHR20
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: Italy
Authorised representative: -
Last updated: 15.07.2026 20:21

Manufacturer products View details

CER-S

CER-S v. 4.y.z

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: CARDIO CALM S.R.L.
Manufacturer SRN: IT-MF-000017950
UDI-DI: B972CCZ12050482050
Basic UDI-DI: ++B972CERS437
Reference: CCZ1205048205
EMDN: Z12050482
EMDN description: HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - SOFTWARE ACCESSORIES
First on market country: Italy
Authorised representative: -
Last updated: 15.07.2026 17:23

Manufacturer products View details

TELECARDIOCALM

Class IIaMDR 2017/745On the market

Manufacturer: CARDIO CALM S.R.L.
Manufacturer SRN: IT-PR-000033759
UDI-DI: +B972CC01020B
Basic UDI-DI: ++B972TELECC32W
Reference: CC0102
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 17:18

Manufacturer products View details

Kardia 12L

AC-027

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: AliveCor, Inc.
Manufacturer SRN: US-MF-000029146
UDI-DI: B210AC0270
Basic UDI-DI: ++B210AC027HU
Reference: AC-027
EMDN: Z12050302
EMDN description: ADVANCED DIAGNOSIS ELECTROCARDIOGRAPHS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 15.07.2026 14:53

Manufacturer products Authorised representative products Authorised representative actors View details

KardiaStation 12L (iOS)

KardiaStation 12L App

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: AliveCor, Inc.
Manufacturer SRN: US-MF-000029146
UDI-DI: B2100020190
Basic UDI-DI: ++B210KS12LS7
Reference: 002019
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 15.07.2026 14:53

Manufacturer products Authorised representative products Authorised representative actors View details

QFR

2024

Class IIaMDR 2017/745On the marketDirect markingMeasuring function

Manufacturer: Medis Medical Imaging Systems bv
Manufacturer SRN: NL-MF-000002670
UDI-DI: B141MEDISQFRXA20240
Basic UDI-DI: ++B141MEDISQFRXA2024JB
Reference: Medis QFR XA 2024
EMDN: Z12050582
EMDN description: CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: -
Last updated: 15.07.2026 14:52

Manufacturer products View details

QFR

2022

Class IIaMDR 2017/745On the marketDirect markingMeasuring function

Manufacturer: Medis Medical Imaging Systems bv
Manufacturer SRN: NL-MF-000002670
UDI-DI: B141MEDISQFRXA20220
Basic UDI-DI: ++B141MEDISQFRXA2022J7
Reference: Medis QFR XA 2022
EMDN: Z12050582
EMDN description: CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: -
Last updated: 15.07.2026 14:52

Manufacturer products View details

BTL Flexi 12 ECG

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: BTL Industries Limited
Manufacturer SRN: GB-MF-000034894
UDI-DI: B108076POFF12MEU00
Basic UDI-DI: ++B108076POEUZF
Reference: C076.014; C076.013; C076.004; C076.003
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Northern Ireland
Authorised representative: BTL ITALIA S.r.l.
Last updated: 15.07.2026 14:50

Manufacturer products Authorised representative products Authorised representative actors View details

B009OCSLungConsoleGY

100003924

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: TransMedics, Inc
Manufacturer SRN: US-MF-000029912
UDI-DI: B009OCSLungConsoleGY
Basic UDI-DI: ++B009OCSLungConsoleGY
Reference: 2000
EMDN: Z12050201
EMDN description: EXTRA-CORPOREAL CIRCULATION SYSTEMS
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:50

Manufacturer products Authorised representative products Authorised representative actors View details

B009OCSLungAccessoryJF

OCS Lung Instrumentation Tool Set

Class IIaMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: TransMedics, Inc
Manufacturer SRN: US-MF-000029912
UDI-DI: B009OCSLungAccessoryJF
Basic UDI-DI: ++B009OCSLungAccessoryJF
Reference: 2401, 2402, 2403, 2404
EMDN: Z12050285
EMDN description: EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - CONSUMABLES
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:50

Manufacturer products Authorised representative products Authorised representative actors View details

B009OCSHeartConsole2E

OCS Heart Console

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: TransMedics, Inc
Manufacturer SRN: US-MF-000029912
UDI-DI: B009OCSHeartConsole2E
Basic UDI-DI: ++B009OCSHeartConsole2E
Reference: 100004929
EMDN: Z12050201
EMDN description: EXTRA-CORPOREAL CIRCULATION SYSTEMS
First on market country: Lithuania
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:50

Manufacturer products Authorised representative products Authorised representative actors View details

B009OCSCommonClass2aGF

OCS Class IIa Accessories/Components

Class IIaMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: TransMedics, Inc
Manufacturer SRN: US-MF-000029912
UDI-DI: B009OCSCommonClass2aGF
Basic UDI-DI: ++B009OCSCommonClass2aGF
Reference: 100004460
EMDN: Z12050285
EMDN description: EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - CONSUMABLES
First on market country: Lithuania
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:50

Manufacturer products Authorised representative products Authorised representative actors View details

Medis QFR XA

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Medis Medical Imaging Systems bv
Manufacturer SRN: NL-MF-000002670
UDI-DI: +B141MEDISQFRXA0
Basic UDI-DI: ++B141MEDISQFRXAJN
Reference: MEDISQFRXA
EMDN: Z12050582
EMDN description: CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: -
Last updated: 15.07.2026 14:47

Manufacturer products View details

iSEKS Ecg

Class IIaMDDOn the marketActive device

Manufacturer: iSEKS diagnostics GmbH
Manufacturer SRN: DE-MF-000016478
UDI-DI: D-iSEKS-EcgEH
Basic UDI-DI: B-iSEKS-EcgEH
Reference: 01.P.30.00
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:19

Manufacturer products View details

D-benecareUYE

benecare U

Class IIaMDDOn the marketActive device

Manufacturer: Shenzhen Benevolence Medical Sci&Tech Co., Ltd.
Manufacturer SRN: CN-MF-000021136
UDI-DI: D-benecareUYE
Basic UDI-DI: B-benecareUYE
Reference: A01
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

D-benecareMXW

benecare M

Class IIaMDDOn the marketActive device

Manufacturer: Shenzhen Benevolence Medical Sci&Tech Co., Ltd.
Manufacturer SRN: CN-MF-000021136
UDI-DI: D-benecareMXW
Basic UDI-DI: B-benecareMXW
Reference: B01
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

Fitbit Irregular Rhythm Notifications

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Fitbit LLC
Manufacturer SRN: US-MF-000007439
UDI-DI: 00810038852720
Basic UDI-DI: 081003885FB604RA
Reference: FB604
EMDN: Z12050382
EMDN description: ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 14:18

Manufacturer products Authorised representative products Authorised representative actors View details